HIV Vaccine Trial in Thai Adults

• Sponsor: U.S. Army Medical Research and Development Command (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00223080
• Collaborator: United States Army Medical Materiel Development Activity (U.S. Fed), Armed Forces Research Institute of Medical Sciences, Thailand (Other), Walter Reed Army Institute of Research (WRAIR) (U.S. Fed), MCM Vaccines B.V. (Industry), VaxGen (Industry), The Emmes Company, LLC (Industry), Ministry of Health, Thailand (Other), Mahidol University (Other), Royal Thai Army Medical Department (Other), Tripler Army Medical Center (U.S. Fed), Henry M. Jackson Foundation for the Advancement of Military Medicine (Other)
• Enrollment: 16,402
• Locations: 8
• Arms: 2
• Duration (Months): 68
• Patients Per Site: 2050.3
• Patients Per Site Per Month: 30.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether immunizations with an integrated combination of ALVAC-HIV (vCP1521) boosted by AIDSVAX gp120 B/E prevent HIV infection in healthy Thai volunteers.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection	Biological: ALVAC-HIV vCP1521 + AIDSVAX; Other: ALVAC Placebo + AIDSVAX Placebo	Phase 3

Detailed Description

A vaccine for the prevention of HIV infection remains an urgent need as part of the efforts to control the HIV pandemic. In this phase III efficacy trial, a 'prime-boost' vaccine strategy is evaluated for prevention of infection and amelioration of disease course. ALVAC-HIV (vCP1521) from sanofi pasteur is given as the 'prime' vaccine at months 0, 1, 3 and 6; AIDSVAX gp120 B/E from VaxGen is given as the 'boost' at months 3 and 6. This regimen will be given to 8,000 adult Thai subjects, while another 8,000 will be given placebos in a double-blinded, randomized manner. Following the completion of each subjects immunization phase, he/she will be followed for 3 years with clinic visits every 6 months with HIV testing, pre- and post-test counseling. Subjects who become HIV infected will be counseled, referred to HIV treatment facilities for management according to national guidelines, and offered enrollment in a protocol for extended follow-up.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16402 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX B/E) Boosting in HIV-uninfected Thai Adults
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vaccine ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24.	Biological: ALVAC-HIV vCP1521 + AIDSVAX; Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL; Other Names: ALVAC-HIV (vCP1521) >106 CCID50 per 1 mL dose AIDSVAX® B/E Bivalent HIV gp120 vaccine subtype B (MN), and E (A244)
Placebo Comparator: Placebo ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4.	Other: ALVAC Placebo + AIDSVAX Placebo; ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection; Other Names: ALVAC carrier lyophilized product without virus Aluminum hydroxide adjuvant

Outcome Measures

Primary Outcome Measures

1. Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population [42 Months]

   HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.

2. Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population [42 Months]

   Cumulative Number of HIV Infections. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.

3. Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population [42 months]

   Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.

4. Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population [42 months]

   Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.

Secondary Outcome Measures

1. Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population [42 weeks]

   Two CD4 cell counts were obtained (at the verification blood draw and the notification blood draw) and through the remainder of the follow-up period. Results were compared in vaccine and placebo recipients who became HIV-infected during the trial.

2. Safety Assessment (SAE's and AEs) [Dose Interval 1: week 0, Dose Interval 2: Week 4, Dose Interval 3: Week 12, and Dose Interval 4: Week 24; every 6 months during 3 year f/u period]

   The intent-to-treat population is used for analysis of AEs and treatment emergent events are reported. Participant AE rates for all AEs, SAEs and treatment-related AEs are summarized

3. Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT) [Week 182]

   Self Report of Risk Behavior Status by Treatment and Time. Specifically, this is the responses to the question "Do you think that your everyday behavior puts you at risk for HIV infection?" Modified intent to treat population (MITT)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Possession of the 13-digit Thai National ID card

• 18-30 years of age (inclusive), male or female

• For women, a negative urine pregnancy test on the day of enrollment, as well as assurance that adequate birth control measures would be applied during the course of the injections and the 3 months after the last injection.

• Absence of systemic disease or immunodeficiency as determined by medical history and directed physical examination.

• Negative serology for HIV-1 infection within 45 days prior to enrollment.

• Availability and commitment for 3.5 years of participation.

• Able to understand the study (shown by receiving a passing score on the Test of Understanding administered under the screening protocol) and gave written informed consent.

• Enrollment in and referral from screening protocol, RV148

Exclusion Criteria:

• Previous participation in any HIV vaccine trial (unless the volunteer could provide documentation that he/she received placebo).

• Active tuberculosis, other systemic disease process, or immunodeficiency as detected by medical history and directed physical examination that would, in the opinion of the investigator, impede compliance with study requirements or complicate the interpretation of adverse events.

• Any significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome from participating in this study or might interfere with the volunteer's ability to successfully complete the study.

• Occupational or other responsibilities that would prevent completion of 3.5 years of participation in the study.

• History of anaphylaxis or other serious adverse reactions to vaccines, or allergies or reactions likely to be exacerbated by any component of the vaccine or placebo, including egg products and neomycin.

• Women breast-feeding or pregnant (positive pregnancy test) or planning to become pregnant during the 9-month window between study enrollment and 3-months after the last vaccination visit.

• Study site employees who were involved in the protocol and may have had direct access to trial-related data.

• Chronic use of therapies which may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of > 20 mg prednisone equivalent for periods exceeding 10 days), and use of experimental drugs or vaccines.

• Receipt of a non-HIV vaccine or immune globulins within 14 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ban Lamung District Hospital	Ban Lamung District	Chon Buri	Thailand
2	Phan Tong District Hospital	Phan Tong District	Chon Buri	Thailand	20160
3	Sattahip District Hospital	Sattahip District	Chon Buri	Thailand	20180
4	Ao Udom Hospital	Sri Racha District	Chon Buri	Thailand	20230
5	Ban Chang District Hospital	Ban Chang District	Rayong	Thailand
6	Ban Khai District Hospital	Ban Khai District	Rayong	Thailand
7	Klaeng District Hospital	Klaeng District	Rayong	Thailand
8	Provincial Health Office	Muang District	Rayong	Thailand	21000

Sponsors and Collaborators

• U.S. Army Medical Research and Development Command
• United States Army Medical Materiel Development Activity
• Armed Forces Research Institute of Medical Sciences, Thailand
• Walter Reed Army Institute of Research (WRAIR)
• MCM Vaccines B.V.
• VaxGen
• The Emmes Company, LLC
• Ministry of Health, Thailand
• Mahidol University
• Royal Thai Army Medical Department
• Tripler Army Medical Center
• Henry M. Jackson Foundation for the Advancement of Military Medicine

Investigators

• Principal Investigator: Supachai Rerks-Ngarm, MD, Ministry of Health, Thailand

Study Documents (Full-Text)

None provided.

More Information

Publications

• Brown AE, Nitayaphan S. Foundations for a Phase III human immunodeficiency virus vaccine trial: A decade of Thai-U.S. Army collaborative research. Mil Med. 2004 Aug;169(8):588-93. Review.
• Karnasuta C, Paris RM, Cox JH, Nitayaphan S, Pitisuttithum P, Thongcharoen P, Brown AE, Gurunathan S, Tartaglia J, Heyward WL, McNeil JG, Birx DL, de Souza MS; Thai AIDS Vaccine Evaluation Group, Thailand. Antibody-dependent cell-mediated cytotoxic responses in participants enrolled in a phase I/II ALVAC-HIV/AIDSVAX B/E prime-boost HIV-1 vaccine trial in Thailand. Vaccine. 2005 Mar 31;23(19):2522-9.
• Nitayaphan S, Pitisuttithum P, Karnasuta C, Eamsila C, de Souza M, Morgan P, Polonis V, Benenson M, VanCott T, Ratto-Kim S, Kim J, Thapinta D, Garner R, Bussaratid V, Singharaj P, el-Habib R, Gurunathan S, Heyward W, Birx D, McNeil J, Brown AE; Thai AIDS Vaccine Evaluation Group. Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults. J Infect Dis. 2004 Aug 15;190(4):702-6. Epub 2004 Jul 20.

• Responsible Party: U.S. Army Medical Research and Development Command
• ClinicalTrials.gov Identifier: NCT00223080
• Other Study ID Numbers: RV144; HSRRB A-11048
• First Posted: Sep 22, 2005
• Last Update Posted: Apr 24, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by U.S. Army Medical Research and Development Command: HIV Seronegativity
• Additional relevant MeSH terms: HIV Infections; Aluminum Hydroxide

Study Results

Participant Flow

Recruitment Details	16,402 subjects were randomized, 16,395 were infection free and assigned treatment groups
Pre-assignment Detail	16,402 individuals were randomly assigned to the 2 treatment arms. 7 individuals were identified as having human immunodeficiency virus (HIV) infection that was present pre-vaccination detected by polymerase chain reaction (PCR) amplification. These individuals were removed from the modified intent to treat (MITT) population.

Arm/Group Title	Vaccine	Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Period Title: Overall Study
STARTED	8197	8198
COMPLETED	7401	7401
NOT COMPLETED	796	797

Baseline Characteristics

Arm/Group Title	Vaccine	Placebo	Total
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection	Total of all reporting groups
Overall Participants	8197	8198	16395
Age, Customized (Count of Participants)
18 - 20	2297 28%	2246 27.4%	4543 27.7%
21 - 25	3633 44.3%	3708 45.2%	7341 44.8%
26 - 30	2267 27.7%	2244 27.4%	4511 27.5%
Sex: Female, Male (Count of Participants)
Female	3164 38.6%	3167 38.6%	6331 38.6%
Male	5033 61.4%	5031 61.4%	10064 61.4%
Province (participants) [Number]
Chon Buri	4107 50.1%	4107 50.1%	8214 50.1%
Rayong	4090 49.9%	4091 49.9%	8181 49.9%
Marital status (participants) [Number]
Single	3353 40.9%	3338 40.7%	6691 40.8%
Married	4110 50.1%	4169 50.9%	8279 50.5%
Divorced	602 7.3%	541 6.6%	1143 7%
Widowed	50 0.6%	64 0.8%	114 0.7%
Separated	82 1%	86 1%	168 1%
Number of sex partners (participants) [Number]
0	1864 22.7%	1801 22%	3665 22.4%
1	5428 66.2%	5495 67%	10923 66.6%
> 1	619 7.6%	620 7.6%	1239 7.6%
Did not answer	280 3.4%	273 3.3%	553 3.4%
Missing data	6 0.1%	9 0.1%	15 0.1%
Risk group (participants) [Number]
Low	3865 47.2%	3924 47.9%	7789 47.5%
Medium	2369 28.9%	2292 28%	4661 28.4%
High	1963 23.9%	1982 24.2%	3945 24.1%

Outcome Measures

1. Primary Outcome

Title	Kaplan-Meier Estimate of HIV-1 Infection Rate in Intent to Treat Population
Description	HIV-1 infection rate. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Time Frame	42 Months

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study

Arm/Group Title	Vaccine	Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Measure Participants	8197	8198
12 months	0.15	0.38
24 months	0.41	0.64
36 months	0.58	0.84
42 months	0.68	0.96

2. Primary Outcome

Title	Vaccine Efficacy as Determined by Acquisition of Infection in the Per-protocol Population
Description	Cumulative Number of HIV Infections. Detection of HIV-1 infection was defined according to the HIV diagnostic algorithm utilizing serologic and nucleic acid technologies. Incidence of HIV infection was compared in the vaccine and placebo-recipient groups.
Time Frame	42 Months

Outcome Measure Data

Analysis Population Description

Per-protocol population: The per-protocol analysis is restricted to the individuals who were infection-free at the completion of vaccination and who received a timely set of 4 vaccinations.

Arm/Group Title	Vaccine	Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Measure Participants	6176	6366
12 months	0.08	0.25
24 months	0.36	0.49
36 months	0.52	0.70
42 months	0.59	0.80

3. Secondary Outcome

Title	Changes in CD4 T Cell Count in Volunteers Who Developed HIV Infection During the Trial for MITT Population
Description	Two CD4 cell counts were obtained (at the verification blood draw and the notification blood draw) and through the remainder of the follow-up period. Results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
Time Frame	42 weeks

Outcome Measure Data

Analysis Population Description

Prior to the analysis, the SAP identified the MITT as those participants who were infection free at entry into the study. Although individuals were screened for HIV antibody prior to entry, individuals identified by laboratory examination of PCR assessments of blinded pre-randomization specimens that were performed subsequent to entry were excluded

Arm/Group Title	Vaccine	Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Measure Participants	51	73
1st verification	565.4 (43.5)	566.7 (26.5)
Notification	539.6 (37.1)	570.6 (29.2)

4. Primary Outcome

Title	Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the MITT Population
Description	Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
Time Frame	42 months

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (MITT) Population: those participants who were infection free at entry into the study

Arm/Group Title	Vaccine	Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Measure Participants	51	73
First positive serology	4.379 (0.127)	4.187 (0.101)
3-weeks post identificaiton	4.229 (0.130)	4.235 (0.095)
~6-weeks post identification	4.274 (0.125)	4.167 (0.104)

5. Primary Outcome

Title	Changes in HIV-1 Viral Load in Volunteers Developing HIV Infection During the Trial for the Per Protocol Population
Description	Log10 HIV-1 viral loads for diagnostic specimens for subjects with post-HIV infection. The trial quantitated HIV plasma viral load at the time of diagnosis and through the remainder of the follow-up period. Peri infection results were compared in vaccine and placebo recipients who became HIV-infected during the trial.
Time Frame	42 months

Outcome Measure Data

Analysis Population Description

Per-protocol population: The per-protocol analysis is restricted to the individuals who were infection-free at the completion of vaccination and who received a timely set of 4 vaccinations.

Arm/Group Title	Vaccine	Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Measure Participants	36	50
First positive serology	4.307 (0.154)	4.153 (0.136)
3-weeks post identificaiton	4.128 (0.161)	4.276 (0.118)
~6-weeks post identification	4.280 (0.152)	4.143 (0.143)

6. Secondary Outcome

Title	Safety Assessment (SAE's and AEs)
Description	The intent-to-treat population is used for analysis of AEs and treatment emergent events are reported. Participant AE rates for all AEs, SAEs and treatment-related AEs are summarized
Time Frame	Dose Interval 1: week 0, Dose Interval 2: Week 4, Dose Interval 3: Week 12, and Dose Interval 4: Week 24; every 6 months during 3 year f/u period

Outcome Measure Data

Analysis Population Description

intent-to-treat population

Arm/Group Title	Vaccine	Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Measure Participants	8197	8198
30-day post dose interval 1	1277	1336
30-day post dose interval 2	816	860
30-day post dose interval 3	614	597
30-day post dose interval 4	599	630
All treatment emergent	5627	5685

7. Secondary Outcome

Title	Change in HIV Risk Behaviors Associated With Participation in the Vaccine Trial (MITT)
Description	Self Report of Risk Behavior Status by Treatment and Time. Specifically, this is the responses to the question "Do you think that your everyday behavior puts you at risk for HIV infection?" Modified intent to treat population (MITT)
Time Frame	Week 182

Outcome Measure Data

Analysis Population Description

Prior to the analysis, the SAP identified the MITT as those participants who were infection free at entry into the study. Although individuals were screened for HIV antibody prior to entry, individuals identified by laboratory examination of PCR assessments of blinded pre-randomization specimens that were performed subsequent to entry were excluded

Arm/Group Title	Vaccine	Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL	ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
Measure Participants	7399	7395
Yes	702 8.6%	763 9.3%
No	6223 75.9%	6130 74.8%
Don't know/Not sure	473 5.8%	502 6.1%
Missing value	1 0%	0 0%

Adverse Events

Time Frame	For serious adverse events - anytime after the first vaccination until final follow-up at week 184. For other adverse events - total post-injection reaction severity
Arm/Group Title	Vaccine		Placebo
Arm/Group Description	ALVAC-HIV vCP1521 + AIDSVAX will both be administered by the intramuscular route (preferably in the deltoid region) on weeks 0, 4, 12, and 24. ALVAC-HIV vCP1521 + AIDSVAX: Combined dose of 600 μg (300 μg of each antigen), co-formulated and administered in alumi-um hydroxide gel at a dose of 600 μg/mL		ALVAC Placebo + AIDSVAX Placebo will be administered at week 12 and 24. ALVAC Placebo only was additionally administered at week 0 and 4. ALVAC Placebo + AIDSVAX Placebo: ALVAC carrier, supplied as a lyophilized product, without virus and Aluminum hydroxide adjuvant, 1.2 mL per vial, given as a 1 mL injection
All Cause Mortality
	Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	85/8197 (1%)		75/8198 (0.9%)
Serious Adverse Events
	Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1175/8197 (14.3%)		1219/8198 (14.9%)
Blood and lymphatic system disorders
Anaemia	0/8197 (0%)		1/8198 (0%)
Anaemia of pregnancy	0/8197 (0%)		1/8198 (0%)
Autoimmune thrombocytopenia	0/8197 (0%)		1/8198 (0%)
Haemorrhagic anaemia	1/8197 (0%)		2/8198 (0%)
Idiopathic thrombocytopenic purpura	1/8197 (0%)		0/8198 (0%)
Cardiac disorders
Angina unstable	0/8197 (0%)		1/8198 (0%)
Arrhythmia	2/8197 (0%)		0/8198 (0%)
Bradycardia	0/8197 (0%)		1/8198 (0%)
Cardiac arrest	0/8197 (0%)		2/8198 (0%)
Cardiac failure	2/8197 (0%)		1/8198 (0%)
Cardiac failure congestive	0/8197 (0%)		2/8198 (0%)
Cardiac valve disease	1/8197 (0%)		0/8198 (0%)
Cardio-respiratory arrest	1/8197 (0%)		1/8198 (0%)
Cardiomegaly	1/8197 (0%)		0/8198 (0%)
Congestive cardiomyopathy	1/8197 (0%)		1/8198 (0%)
Extrasystoles	2/8197 (0%)		2/8198 (0%)
Mitral valve stenosis	1/8197 (0%)		0/8198 (0%)
Myocarditis	1/8197 (0%)		0/8198 (0%)
Ventricular extrasystoles	0/8197 (0%)		1/8198 (0%)
Wolff-Parkinson-White syndrome	1/8197 (0%)		0/8198 (0%)
Congenital, familial and genetic disorders
Atrial septal defect	2/8197 (0%)		0/8198 (0%)
Cleft lip	1/8197 (0%)		0/8198 (0%)
Cleft lip and palate	1/8197 (0%)		0/8198 (0%)
Cleft palate	0/8197 (0%)		1/8198 (0%)
Congenital anomaly	2/8197 (0%)		0/8198 (0%)
Congenital heart valve disorder	1/8197 (0%)		0/8198 (0%)
Congenital inguinal hernia	1/8197 (0%)		0/8198 (0%)
Congenital megacolon	1/8197 (0%)		0/8198 (0%)
Congenital skin disorder	0/8197 (0%)		1/8198 (0%)
Ebstein's anomaly	1/8197 (0%)		0/8198 (0%)
Familial periodic paralysis	0/8197 (0%)		1/8198 (0%)
Foetal cystic hygroma	1/8197 (0%)		0/8198 (0%)
Glucose-6-phosphate dehydrogenase deficiency	5/8197 (0.1%)		1/8198 (0%)
Hydrocele	0/8197 (0%)		1/8198 (0%)
Limb malformation	0/8197 (0%)		1/8198 (0%)
Multiple congenital abnormalities	0/8197 (0%)		1/8198 (0%)
Patent ductus arteriosus	1/8197 (0%)		0/8198 (0%)
Polydactyly	0/8197 (0%)		2/8198 (0%)
Thyroglossal cyst	1/8197 (0%)		0/8198 (0%)
Transposition of the great vessels	1/8197 (0%)		0/8198 (0%)
Trisomy 21	0/8197 (0%)		1/8198 (0%)
Urachal abnormality	1/8197 (0%)		0/8198 (0%)
Ventricular septal defect	2/8197 (0%)		2/8198 (0%)
Ear and labyrinth disorders
Auricular perichondritis	1/8197 (0%)		0/8198 (0%)
Vertigo	2/8197 (0%)		2/8198 (0%)
Vertigo positional	0/8197 (0%)		1/8198 (0%)
Endocrine disorders
Adrenal insufficiency	0/8197 (0%)		1/8198 (0%)
Goitre	0/8197 (0%)		2/8198 (0%)
Hyperthyroidism	1/8197 (0%)		0/8198 (0%)
Thyrotoxic crisis	1/8197 (0%)		0/8198 (0%)
Thyrotoxic periodic paralysis	1/8197 (0%)		0/8198 (0%)
Eye disorders
Photokeratitis	1/8197 (0%)		0/8198 (0%)
Ulcerative keratitis	2/8197 (0%)		0/8198 (0%)
Gastrointestinal disorders
Abdominal hernia obstructive	1/8197 (0%)		0/8198 (0%)
Abdominal pain	8/8197 (0.1%)		7/8198 (0.1%)
Abdominal pain lower	1/8197 (0%)		1/8198 (0%)
Alcoholic pancreatitis	0/8197 (0%)		1/8198 (0%)
Anal fissure	0/8197 (0%)		1/8198 (0%)
Anal polyp	0/8197 (0%)		1/8198 (0%)
Appendicitis perforated	8/8197 (0.1%)		5/8198 (0.1%)
Diarrhoea	8/8197 (0.1%)		12/8198 (0.1%)
Duodenal ulcer	0/8197 (0%)		1/8198 (0%)
Duodenal ulcer haemorrhage	3/8197 (0%)		1/8198 (0%)
Dyspepsia	13/8197 (0.2%)		15/8198 (0.2%)
Enteritis	4/8197 (0%)		3/8198 (0%)
Enterocolitis	0/8197 (0%)		1/8198 (0%)
Food poisoning	4/8197 (0%)		2/8198 (0%)
Gastritis	10/8197 (0.1%)		14/8198 (0.2%)
Gastritis alcoholic	0/8197 (0%)		1/8198 (0%)
Gastritis alcoholic haemorrhagic	0/8197 (0%)		1/8198 (0%)
Gastritis haemorrhagic	1/8197 (0%)		1/8198 (0%)
Gastroduodenitis	1/8197 (0%)		0/8198 (0%)
Gastroduodenitis haemorrhagic	0/8197 (0%)		1/8198 (0%)
Gastrointestinal haemorrhage	1/8197 (0%)		0/8198 (0%)
Gastrooesophageal reflux disease	0/8197 (0%)		1/8198 (0%)
Haemorrhoidal haemorrhage	1/8197 (0%)		1/8198 (0%)
Haemorrhoids	3/8197 (0%)		3/8198 (0%)
Ileus	1/8197 (0%)		0/8198 (0%)
Inguinal hernia	10/8197 (0.1%)		10/8198 (0.1%)
Inguinal hernia, obstructive	2/8197 (0%)		1/8198 (0%)
Intestinal obstruction	4/8197 (0%)		1/8198 (0%)
Oesophageal ulcer	1/8197 (0%)		0/8198 (0%)
Pancreatitis acute	1/8197 (0%)		0/8198 (0%)
Peptic ulcer	6/8197 (0.1%)		8/8198 (0.1%)
Peptic ulcer perforation	4/8197 (0%)		0/8198 (0%)
Upper gastrointestinal haemorrhage	5/8197 (0.1%)		6/8198 (0.1%)
Volvulus	1/8197 (0%)		0/8198 (0%)
Vomiting	1/8197 (0%)		0/8198 (0%)
General disorders
Chest pain	1/8197 (0%)		0/8198 (0%)
Death	0/8197 (0%)		1/8198 (0%)
Drowning	1/8197 (0%)		4/8198 (0%)
Electrocution	0/8197 (0%)		2/8198 (0%)
Fatigue	1/8197 (0%)		0/8198 (0%)
Foreign body reaction	1/8197 (0%)		0/8198 (0%)
Lipogranuloma	0/8197 (0%)		1/8198 (0%)
Pyrexia	7/8197 (0.1%)		14/8198 (0.2%)
Sudden death	0/8197 (0%)		1/8198 (0%)
Cholangitis acute	1/8197 (0%)		0/8198 (0%)
Cholecystitis acute	2/8197 (0%)		0/8198 (0%)
Cholecystitis chronic	1/8197 (0%)		0/8198 (0%)
Cholelithiasis	1/8197 (0%)		0/8198 (0%)
Gallbladder polyp	1/8197 (0%)		0/8198 (0%)
Hepatitis	2/8197 (0%)		2/8198 (0%)
Hepatitis alcoholic	0/8197 (0%)		2/8198 (0%)
Hepatitis fulminant	0/8197 (0%)		1/8198 (0%)
Jaundice cholestatic	0/8197 (0%)		1/8198 (0%)
Post cholecystectomy syndrome	1/8197 (0%)		0/8198 (0%)
Immune system disorders
Allergy to arthropod bite	1/8197 (0%)		1/8198 (0%)
Allergy to arthropod sting	1/8197 (0%)		4/8198 (0%)
Anaphylactic reaction	4/8197 (0%)		4/8198 (0%)
Anaphylactic shock	0/8197 (0%)		1/8198 (0%)
Drug hypersensitivity	2/8197 (0%)		1/8198 (0%)
Food allergy	1/8197 (0%)		2/8198 (0%)
Immune reconstitution syndrome	1/8197 (0%)		0/8198 (0%)
Infections and infestations
Abortion infected	1/8197 (0%)		2/8198 (0%)
Abscess	0/8197 (0%)		1/8198 (0%)
Abscess jaw	1/8197 (0%)		1/8198 (0%)
Abscess limb	2/8197 (0%)		2/8198 (0%)
Abscess neck	0/8197 (0%)		1/8198 (0%)
Abscess oral	0/8197 (0%)		1/8198 (0%)
Acute sinusitis	1/8197 (0%)		1/8198 (0%)
Acute tonsillitis	6/8197 (0.1%)		10/8198 (0.1%)
Amoebic dysentery	1/8197 (0%)		0/8198 (0%)
Anal abscess	3/8197 (0%)		1/8198 (0%)
Anogenital warts	1/8197 (0%)		0/8198 (0%)
Appendicitis	54/8197 (0.7%)		61/8198 (0.7%)
Bacteraemia	1/8197 (0%)		0/8198 (0%)
Bacterial labyrinthitis	0/8197 (0%)		1/8198 (0%)
Bacterial sepsis	0/8197 (0%)		1/8198 (0%)
Bartholin's abscess	0/8197 (0%)		1/8198 (0%)
Breast abscess	0/8197 (0%)		2/8198 (0%)
Bronchitis	7/8197 (0.1%)		11/8198 (0.1%)
Cellulitis	4/8197 (0%)		6/8198 (0.1%)
Chronic tonsillitis	0/8197 (0%)		1/8198 (0%)
Cystitis	2/8197 (0%)		3/8198 (0%)
Dengue fever	57/8197 (0.7%)		45/8198 (0.5%)
Dermatitis infected	1/8197 (0%)		0/8198 (0%)
Diarrhoea infectious	4/8197 (0%)		2/8198 (0%)
Disseminated tuberculosis	0/8197 (0%)		1/8198 (0%)
Diverticulitis	0/8197 (0%)		1/8198 (0%)
Endocarditis	0/8197 (0%)		1/8198 (0%)
Endometritis	1/8197 (0%)		0/8198 (0%)
Endometritis decidual	1/8197 (0%)		0/8198 (0%)
Gastroenteritis	19/8197 (0.2%)		22/8198 (0.3%)
Gastroenteritis bacterial	1/8197 (0%)		0/8198 (0%)
Giardiasis	1/8197 (0%)		0/8198 (0%)
Hepatitis A	2/8197 (0%)		0/8198 (0%)
Hepatitis B	4/8197 (0%)		3/8198 (0%)
Hepatitis viral	0/8197 (0%)		1/8198 (0%)
Hookworm infection	1/8197 (0%)		0/8198 (0%)
Infected bites	0/8197 (0%)		1/8198 (0%)
Infected cyst	0/8197 (0%)		1/8198 (0%)
Infected skin ulcer	1/8197 (0%)		0/8198 (0%)
Infection	3/8197 (0%)		1/8198 (0%)
Infection in an immunocompromised host	1/8197 (0%)		0/8198 (0%)
Influenza	3/8197 (0%)		11/8198 (0.1%)
Leptospirosis	1/8197 (0%)		2/8198 (0%)
Liver abscess	0/8197 (0%)		1/8198 (0%)
Lobar pneumonia	1/8197 (0%)		0/8198 (0%)
Lymph node tuberculosis	1/8197 (0%)		0/8198 (0%)
Malaria	4/8197 (0%)		2/8198 (0%)
Measles	4/8197 (0%)		2/8198 (0%)
Meningitis	1/8197 (0%)		0/8198 (0%)
Meningitis aseptic	1/8197 (0%)		1/8198 (0%)
Meningitis bacterial	1/8197 (0%)		0/8198 (0%)
Meningitis tuberculous	1/8197 (0%)		1/8198 (0%)
Meningitis viral	2/8197 (0%)		0/8198 (0%)
Mumps	1/8197 (0%)		0/8198 (0%)
Murine typhus	1/8197 (0%)		0/8198 (0%)
Muscle abscess	1/8197 (0%)		0/8198 (0%)
Nasopharyngitis	1/8197 (0%)		1/8198 (0%)
Orchitis	2/8197 (0%)		2/8198 (0%)
Osteomyelitis	1/8197 (0%)		0/8198 (0%)
Osteomyelitis chronic	4/8197 (0%)		0/8198 (0%)
Paronychia	0/8197 (0%)		1/8198 (0%)
Pelvic inflammatory disease	14/8197 (0.2%)		12/8198 (0.1%)
Perineal infection	1/8197 (0%)		0/8198 (0%)
Periorbital cellulitis	0/8197 (0%)		1/8198 (0%)
Peritonsillar abscess	1/8197 (0%)		1/8198 (0%)
Pharyngitis	24/8197 (0.3%)		20/8198 (0.2%)
Pharyngitis streptococcal	0/8197 (0%)		1/8198 (0%)
Pharyngotonsillitis	4/8197 (0%)		2/8198 (0%)
Plasmodium falciparum infection	1/8197 (0%)		3/8198 (0%)
Pneumocystis jiroveci pneumonia	1/8197 (0%)		1/8198 (0%)
Pneumonia	10/8197 (0.1%)		9/8198 (0.1%)
Pneumonia bacterial	0/8197 (0%)		2/8198 (0%)
Pneumonia measles	1/8197 (0%)		0/8198 (0%)
Pneumonia primary atypical	1/8197 (0%)		0/8198 (0%)
Post procedural infection	1/8197 (0%)		3/8198 (0%)
Postoperative wound infection	3/8197 (0%)		3/8198 (0%)
Pulmonary tuberculosis	2/8197 (0%)		4/8198 (0%)
Pyelonephritis	1/8197 (0%)		2/8198 (0%)
Pyelonephritis acute	14/8197 (0.2%)		26/8198 (0.3%)
Pyomyositis	0/8197 (0%)		1/8198 (0%)
Respiratory tract infection	0/8197 (0%)		1/8198 (0%)
Rickettsiosis	1/8197 (0%)		0/8198 (0%)
Rubella	1/8197 (0%)		0/8198 (0%)
Salmonellosis	1/8197 (0%)		0/8198 (0%)
Salpingitis	0/8197 (0%)		2/8198 (0%)
Scrub typhus	4/8197 (0%)		1/8198 (0%)
Sepsis	5/8197 (0.1%)		4/8198 (0%)
Sialoadenitis	1/8197 (0%)		0/8198 (0%)
Sinusitis	2/8197 (0%)		2/8198 (0%)
Subcutaneous abscess	0/8197 (0%)		1/8198 (0%)
Tonsillitis	11/8197 (0.1%)		7/8198 (0.1%)
Tooth abscess	2/8197 (0%)		0/8198 (0%)
Tuberculosis	0/8197 (0%)		1/8198 (0%)
Tuberculous pleurisy	1/8197 (0%)		1/8198 (0%)
Typhoid fever	3/8197 (0%)		3/8198 (0%)
Upper respiratory tract infection	6/8197 (0.1%)		15/8198 (0.2%)
Urinary tract infection	14/8197 (0.2%)		16/8198 (0.2%)
Vaginal cellulitis	1/8197 (0%)		0/8198 (0%)
Varicella	1/8197 (0%)		1/8198 (0%)
Viral infection	10/8197 (0.1%)		13/8198 (0.2%)
Viral skin infection	2/8197 (0%)		2/8198 (0%)
Wound infection	5/8197 (0.1%)		8/8198 (0.1%)
Penetrating abdominal trauma	1/8197 (0%)		0/8198 (0%)
Poisoning deliberate	2/8197 (0%)		0/8198 (0%)
Testicular injury	1/8197 (0%)		0/8198 (0%)
Ulna fracture	4/8197 (0%)		2/8198 (0%)
Urinary bladder rupture	1/8197 (0%)		0/8198 (0%)
Injury, poisoning and procedural complications
Abdominal injury	0/8197 (0%)		1/8198 (0%)
Accident	24/8197 (0.3%)		22/8198 (0.3%)
Accident at home	1/8197 (0%)		0/8198 (0%)
Accident at work	1/8197 (0%)		1/8198 (0%)
Alcohol poisoning	0/8197 (0%)		2/8198 (0%)
Animal bite	2/8197 (0%)		1/8198 (0%)
Ankle fracture	1/8197 (0%)		0/8198 (0%)
Arterial injury	1/8197 (0%)		0/8198 (0%)
Arthropod bite	1/8197 (0%)		2/8198 (0%)
Arthropod sting	0/8197 (0%)		2/8198 (0%)
Brain contusion	1/8197 (0%)		0/8198 (0%)
Burns first degree	0/8197 (0%)		1/8198 (0%)
Burns second degree	0/8197 (0%)		3/8198 (0%)
Cataract traumatic	1/8197 (0%)		1/8198 (0%)
Caustic injury	1/8197 (0%)		2/8198 (0%)
Chemical eye injury	1/8197 (0%)		0/8198 (0%)
Chemical injury	0/8197 (0%)		1/8198 (0%)
Chemical poisoning	1/8197 (0%)		5/8198 (0.1%)
Chest injury	1/8197 (0%)		0/8198 (0%)
Compression fracture	1/8197 (0%)		0/8198 (0%)
Concussion	6/8197 (0.1%)		6/8198 (0.1%)
Contusion	1/8197 (0%)		1/8198 (0%)
Crushing injury of trunk	1/8197 (0%)		0/8198 (0%)
Drug toxicity	0/8197 (0%)		1/8198 (0%)
Electric shock	1/8197 (0%)		1/8198 (0%)
Exposure to toxic agent	2/8197 (0%)		0/8198 (0%)
Extradural haematoma	1/8197 (0%)		0/8198 (0%)
Eye injury	0/8197 (0%)		1/8198 (0%)
Eye penetration	0/8197 (0%)		1/8198 (0%)
Face injury	1/8197 (0%)		0/8198 (0%)
Facial bones fracture	3/8197 (0%)		4/8198 (0%)
Fall	14/8197 (0.2%)		7/8198 (0.1%)
Femur fracture	1/8197 (0%)		2/8198 (0%)
Forearm fracture	1/8197 (0%)		2/8198 (0%)
Foreign body in eye	1/8197 (0%)		1/8198 (0%)
Gun shot wound	20/8197 (0.2%)		21/8198 (0.3%)
Hand fracture	2/8197 (0%)		4/8198 (0%)
Head injury	4/8197 (0%)		6/8198 (0.1%)
Humerus fracture	1/8197 (0%)		0/8198 (0%)
Induced abortion haemorrhage	1/8197 (0%)		0/8198 (0%)
Injury	6/8197 (0.1%)		15/8198 (0.2%)
Intentional overdose	1/8197 (0%)		0/8198 (0%)
Jaw fracture	2/8197 (0%)		4/8198 (0%)
Joint dislocation	0/8197 (0%)		1/8198 (0%)
Joint injury	0/8197 (0%)		1/8198 (0%)
Laceration	3/8197 (0%)		3/8198 (0%)
Ligament rupture	1/8197 (0%)		0/8198 (0%)
Limb crushing injury	0/8197 (0%)		1/8198 (0%)
Limb injury	0/8197 (0%)		2/8198 (0%)
Limb traumatic amputation	2/8197 (0%)		0/8198 (0%)
Medical device complication	0/8197 (0%)		1/8198 (0%)
Multiple fractures	0/8197 (0%)		1/8198 (0%)
Multiple injuries	9/8197 (0.1%)		12/8198 (0.1%)
Muscle injury	2/8197 (0%)		2/8198 (0%)
Muscle strain	0/8197 (0%)		3/8198 (0%)
Near drowning	0/8197 (0%)		1/8198 (0%)
Open fracture	0/8197 (0%)		1/8198 (0%)
Open wound	2/8197 (0%)		2/8198 (0%)
Overdose	6/8197 (0.1%)		7/8198 (0.1%)
Peripheral nerve injury	1/8197 (0%)		0/8198 (0%)
Pneumothorax traumatic	1/8197 (0%)		0/8198 (0%)
Post procedural complication	0/8197 (0%)		5/8198 (0.1%)
Post procedural haemorrhage	0/8197 (0%)		1/8198 (0%)
Procedural pain	0/8197 (0%)		3/8198 (0%)
Radius fracture	0/8197 (0%)		1/8198 (0%)
Renal injury	1/8197 (0%)		0/8198 (0%)
Road traffic accident	322/8197 (3.9%)		318/8198 (3.9%)
Sciatic nerve injury	0/8197 (0%)		1/8198 (0%)
Skin laceration	3/8197 (0%)		5/8198 (0.1%)
Skull fracture	1/8197 (0%)		2/8198 (0%)
Snake bite	9/8197 (0.1%)		8/8198 (0.1%)
Soft tissue injury	0/8197 (0%)		1/8198 (0%)
Sports injury	3/8197 (0%)		4/8198 (0%)
Tendon injury	2/8197 (0%)		3/8198 (0%)
Tendon rupture	1/8197 (0%)		1/8198 (0%)
Thermal burn	1/8197 (0%)		0/8198 (0%)
Traumatic brain injury	2/8197 (0%)		0/8198 (0%)
Traumatic haematoma	1/8197 (0%)		0/8198 (0%)
Traumatic intracranial haemorrhage	2/8197 (0%)		2/8198 (0%)
Traumatic shock	1/8197 (0%)		0/8198 (0%)
Wrist fracture	1/8197 (0%)		0/8198 (0%)
Metabolism and nutrition disorders
Diabetes mellitus inadequate control	2/8197 (0%)		0/8198 (0%)
Gestational diabetes	0/8197 (0%)		3/8198 (0%)
Glucose tolerance impaired in pregnancy	0/8197 (0%)		1/8198 (0%)
Hypokalaemia	3/8197 (0%)		0/8198 (0%)
Type 2 diabetes mellitus	0/8197 (0%)		1/8198 (0%)
Musculoskeletal and connective tissue disorders
Back pain	2/8197 (0%)		2/8198 (0%)
Fistula	0/8197 (0%)		1/8198 (0%)
Fracture delayed union	0/8197 (0%)		1/8198 (0%)
Fracture malunion	1/8197 (0%)		0/8198 (0%)
Fracture nonunion	1/8197 (0%)		1/8198 (0%)
Groin pain	0/8197 (0%)		1/8198 (0%)
Intervertebral disc protrusion	2/8197 (0%)		2/8198 (0%)
Myalgia	0/8197 (0%)		1/8198 (0%)
Myofascial pain syndrome	0/8197 (0%)		1/8198 (0%)
Osteochondrosis	0/8197 (0%)		1/8198 (0%)
Osteonecrosis	1/8197 (0%)		0/8198 (0%)
Rhabdomyolysis	1/8197 (0%)		1/8198 (0%)
Spondylolysis	1/8197 (0%)		0/8198 (0%)
Synovial cyst	0/8197 (0%)		1/8198 (0%)
Systemic lupus erythematosus	0/8197 (0%)		1/8198 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix	0/8197 (0%)		1/8198 (0%)
Angiocentric lymphoma stage II	0/8197 (0%)		1/8198 (0%)
Bronchioloalveolar carcinoma	0/8197 (0%)		1/8198 (0%)
Chronic myeloid leukaemia	0/8197 (0%)		1/8198 (0%)
Colon cancer	1/8197 (0%)		0/8198 (0%)
Fibroadenoma of breast	1/8197 (0%)		1/8198 (0%)
Gastric cancer	1/8197 (0%)		0/8198 (0%)
Germ cell cancer	1/8197 (0%)		0/8198 (0%)
Haemangioma	0/8197 (0%)		1/8198 (0%)
Lipoma	1/8197 (0%)		0/8198 (0%)
Nasopharyngeal cancer	1/8197 (0%)		0/8198 (0%)
Non-Hodgkin's lymphoma stage II	1/8197 (0%)		0/8198 (0%)
Oesophageal adenocarcinoma	1/8197 (0%)		0/8198 (0%)
Ovarian adenoma	0/8197 (0%)		1/8198 (0%)
Pituitary tumour benign	0/8197 (0%)		1/8198 (0%)
Salivary gland cancer	0/8197 (0%)		1/8198 (0%)
Sarcoma metastatic	0/8197 (0%)		1/8198 (0%)
Thyroid cancer	0/8197 (0%)		1/8198 (0%)
Thyroid neoplasm	0/8197 (0%)		1/8198 (0%)
Nervous system disorders
Alcoholic seizure	3/8197 (0%)		1/8198 (0%)
Cerebral infarction	1/8197 (0%)		0/8198 (0%)
Cerebrovascular accident	0/8197 (0%)		1/8198 (0%)
Convulsion	2/8197 (0%)		1/8198 (0%)
Demyelination	1/8197 (0%)		0/8198 (0%)
Dizziness	3/8197 (0%)		2/8198 (0%)
Encephalitis	1/8197 (0%)		1/8198 (0%)
Epilepsy	2/8197 (0%)		2/8198 (0%)
Grand mal convulsion	0/8197 (0%)		1/8198 (0%)
Headache	1/8197 (0%)		3/8198 (0%)
Migraine	5/8197 (0.1%)		3/8198 (0%)
Myelitis transverse	0/8197 (0%)		1/8198 (0%)
Optic neuritis	0/8197 (0%)		1/8198 (0%)
Paraplegia	1/8197 (0%)		0/8198 (0%)
Post-traumatic epilepsy	0/8197 (0%)		2/8198 (0%)
Syncope	3/8197 (0%)		2/8198 (0%)
Tension headache	4/8197 (0%)		1/8198 (0%)
Transient ischaemic attack	0/8197 (0%)		1/8198 (0%)
Vascular headache	0/8197 (0%)		2/8198 (0%)
Pregnancy, puerperium and perinatal conditions
Abortion	1/8197 (0%)		0/8198 (0%)
Abortion complete	10/8197 (0.1%)		16/8198 (0.2%)
Abortion incomplete	13/8197 (0.2%)		10/8198 (0.1%)
Abortion incomplete complicated	1/8197 (0%)		0/8198 (0%)
Abortion missed	3/8197 (0%)		2/8198 (0%)
Abortion spontaneous	73/8197 (0.9%)		54/8198 (0.7%)
Abortion spontaneous complete	1/8197 (0%)		1/8198 (0%)
Abortion spontaneous incomplete	1/8197 (0%)		0/8198 (0%)
Abortion threatened	4/8197 (0%)		4/8198 (0%)
Arrested labour	0/8197 (0%)		1/8198 (0%)
Blighted ovum	1/8197 (0%)		0/8198 (0%)
Breech presentation	0/8197 (0%)		1/8198 (0%)
Cephalo-pelvic disproportion	6/8197 (0.1%)		7/8198 (0.1%)
Complication of pregnancy	0/8197 (0%)		1/8198 (0%)
Eclampsia	1/8197 (0%)		0/8198 (0%)
Ectopic pregnancy	3/8197 (0%)		12/8198 (0.1%)
False labour	2/8197 (0%)		4/8198 (0%)
Foetal distress syndrome	1/8197 (0%)		1/8198 (0%)
Foetal growth retardation	0/8197 (0%)		1/8198 (0%)
Hydrops foetalis	0/8197 (0%)		1/8198 (0%)
Hyperemesis gravidarum	10/8197 (0.1%)		13/8198 (0.2%)
Intra-uterine death	0/8197 (0%)		2/8198 (0%)
Labour complication	1/8197 (0%)		0/8198 (0%)
Obstructed labour	1/8197 (0%)		0/8198 (0%)
Oligohydramnios	1/8197 (0%)		0/8198 (0%)
Placenta praevia	5/8197 (0.1%)		5/8198 (0.1%)
Polyhydramnios	1/8197 (0%)		0/8198 (0%)
Post abortion haemorrhage	0/8197 (0%)		1/8198 (0%)
Postpartum haemorrhage	5/8197 (0.1%)		7/8198 (0.1%)
Pre-eclampsia	12/8197 (0.1%)		12/8198 (0.1%)
Pregnancy induced hypertension	6/8197 (0.1%)		5/8198 (0.1%)
Premature labour	5/8197 (0.1%)		3/8198 (0%)
Premature rupture of membranes	5/8197 (0.1%)		12/8198 (0.1%)
Premature separation of placenta	0/8197 (0%)		1/8198 (0%)
Prolonged labour	1/8197 (0%)		0/8198 (0%)
Prolonged pregnancy	0/8197 (0%)		1/8198 (0%)
Retained placenta or membranes	1/8197 (0%)		1/8198 (0%)
Ruptured ectopic pregnancy	2/8197 (0%)		1/8198 (0%)
Stillbirth	3/8197 (0%)		4/8198 (0%)
Third stage postpartum haemorrhage	0/8197 (0%)		1/8198 (0%)
Threatened labour	6/8197 (0.1%)		9/8198 (0.1%)
Umbilical cord prolapse	1/8197 (0%)		0/8198 (0%)
Psychiatric disorders
Acute psychosis	0/8197 (0%)		2/8198 (0%)
Adjustment disorder with depressed mood	0/8197 (0%)		2/8198 (0%)
Alcohol withdrawal syndrome	0/8197 (0%)		1/8198 (0%)
Anxiety	0/8197 (0%)		2/8198 (0%)
Completed suicide	10/8197 (0.1%)		6/8198 (0.1%)
Depression	0/8197 (0%)		2/8198 (0%)
Major depression	1/8197 (0%)		0/8198 (0%)
Psychotic disorder	1/8197 (0%)		1/8198 (0%)
Schizophrenia	1/8197 (0%)		0/8198 (0%)
Schizophrenia, paranoid type	0/8197 (0%)		3/8198 (0%)
Suicide attempt	24/8197 (0.3%)		23/8198 (0.3%)
Renal and urinary disorders
Calculus bladder	0/8197 (0%)		1/8198 (0%)
Calculus ureteric	4/8197 (0%)		2/8198 (0%)
Calculus urinary	2/8197 (0%)		0/8198 (0%)
Nephrotic syndrome	3/8197 (0%)		3/8198 (0%)
Renal failure	1/8197 (0%)		1/8198 (0%)
Renal failure acute	1/8197 (0%)		2/8198 (0%)
Renal failure chronic	0/8197 (0%)		1/8198 (0%)
Stag horn calculus	0/8197 (0%)		1/8198 (0%)
Tubulointerstitial nephritis	1/8197 (0%)		0/8198 (0%)
Urinary retention	0/8197 (0%)		1/8198 (0%)
Reproductive system and breast disorders
Adenomyosis	1/8197 (0%)		0/8198 (0%)
Cervical dysplasia	1/8197 (0%)		0/8198 (0%)
Dysfunctional uterine bleeding	1/8197 (0%)		3/8198 (0%)
Dysmenorrhoea	0/8197 (0%)		1/8198 (0%)
Endometriosis	1/8197 (0%)		2/8198 (0%)
Menorrhagia	0/8197 (0%)		1/8198 (0%)
Ovarian cyst	2/8197 (0%)		2/8198 (0%)
Ovarian cyst ruptured	3/8197 (0%)		3/8198 (0%)
Ovarian cyst torsion	3/8197 (0%)		0/8198 (0%)
Ovarian mass	1/8197 (0%)		0/8198 (0%)
Pelvic pain	1/8197 (0%)		0/8198 (0%)
Prostatitis	1/8197 (0%)		0/8198 (0%)
Varicocele	1/8197 (0%)		0/8198 (0%)
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/8197 (0%)		0/8198 (0%)
Asthma	6/8197 (0.1%)		5/8198 (0.1%)
Bronchitis chronic	0/8197 (0%)		1/8198 (0%)
Epistaxis	0/8197 (0%)		1/8198 (0%)
Haemothorax	3/8197 (0%)		0/8198 (0%)
Hyperventilation	0/8197 (0%)		5/8198 (0.1%)
Nasal polyps	1/8197 (0%)		1/8198 (0%)
Pneumonia aspiration	1/8197 (0%)		1/8198 (0%)
Pneumothorax	3/8197 (0%)		1/8198 (0%)
Skin and subcutaneous tissue disorders
Angioedema	1/8197 (0%)		4/8198 (0%)
Dermatitis allergic	0/8197 (0%)		1/8198 (0%)
Pemphigus	1/8197 (0%)		0/8198 (0%)
Pityriasis	1/8197 (0%)		0/8198 (0%)
Psoriasis	0/8197 (0%)		1/8198 (0%)
Rash	1/8197 (0%)		0/8198 (0%)
Rash pruritic	0/8197 (0%)		1/8198 (0%)
Skin ulcer	0/8197 (0%)		1/8198 (0%)
Urticaria	4/8197 (0%)		2/8198 (0%)
Social circumstances
Physical assault	0/8197 (0%)		1/8198 (0%)
Surgical and medical procedures
Abortion induced	3/8197 (0%)		5/8198 (0.1%)
Caesarean section	0/8197 (0%)		1/8198 (0%)
Endometriosis ablation	1/8197 (0%)		0/8198 (0%)
Vascular disorders
Hypovolaemic shock	1/8197 (0%)		0/8198 (0%)
Varicose vein	1/8197 (0%)		0/8198 (0%)
Other (Not Including Serious) Adverse Events
	Vaccine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7442/8197 (90.8%)		6141/8198 (74.9%)
General disorders
Headache	3677/8197 (44.9%)		2522/8198 (30.8%)
Fatigue	5182/8197 (63.2%)		3410/8198 (41.6%)
Nausea/Vomiting	1030/8197 (12.6%)		802/8198 (9.8%)
Myalgia	4237/8197 (51.7%)		2494/8198 (30.4%)
Arthralgia	2177/8197 (26.6%)		1246/8198 (15.2%)
Oral Temperature	1564/8197 (19.1%)		1009/8198 (12.3%)
Pain/Tenderness	6852/8197 (83.6%)		3727/8198 (45.5%)
Swelling	2325/8197 (28.4%)		432/8198 (5.3%)
Arm Movement Limitation	5647/8197 (68.9%)		2129/8198 (26%)
Induration	316/8197 (3.9%)		108/8198 (1.3%)
Erythema	283/8197 (3.5%)		177/8198 (2.2%)
Pain/Tenderness	3543/8197 (43.2%)		2991/8198 (36.5%)
Swelling	643/8197 (7.8%)		379/8198 (4.6%)
Arm Movement Limitation	2627/8197 (32%)		1943/8198 (23.7%)
Skin and subcutaneous tissue disorders
Rash	266/8197 (3.2%)		273/8198 (3.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.