Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults

• Sponsor: PATH Vaccine Solutions (Other)
• Overall Status: Completed
• CT.gov ID: NCT01537185
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 4
• Duration (Months): 14
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.

Condition or Disease	Intervention/Treatment	Phase
Pneumococcal Vaccines	Other: Placebo; Biological: SPWCV+Alum 100 mcg; Biological: SPWCV+Alum 600 mcg; Biological: SPWCV+Alum 300 mcg	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 SPWCV+Alum 100 mcg each individual receiving 3 vaccinations of same dose 28 days apart	Biological: SPWCV+Alum 100 mcg; 3 injections 28 days apart
Experimental: Cohort 2 SPWCV+Alum 300 mcg each individual receiving 3 vaccinations of same dose 28 days apart	Biological: SPWCV+Alum 300 mcg; 3 injections 28 days apart
Experimental: Cohort 3 SPWCV+Alum 600 mcg each individual receiving 3 vaccinations of same dose 28 days apart	Biological: SPWCV+Alum 600 mcg; 3 injections 28 days apart
Placebo Comparator: Normal Saline Injection placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection	Other: Placebo; 3 cohorts of normal saline injection

Outcome Measures

Primary Outcome Measures

1. Unsolicited Adverse Event Reports [within 1 week (0-7 days) following each vaccinations]

   Safety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination

Secondary Outcome Measures

1. Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG [28, 56 and 84 days following initial vaccination]

   • Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria, Healthy adults:

• If female, not breastfeeding, not pregnant, not planning pregnancy during study period), and willing to consistently use an adequate method of contraception and have repeated pregnancy tests.

• In good health with normal laboratory results

• Willing to comply with study restrictions, study schedule, and can be reliably contacted

Exclusion Criteria:

• Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women.

• current use or likely requirement for medications with potential for liver injury or effect immune system

• History of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease

• History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as HIV, Hepatitis B or C

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Clinical Development	Tacoma	Washington	United States	98418

Sponsors and Collaborators

• PATH Vaccine Solutions

Investigators

• Principal Investigator: Royce Morrison, M.D., Comprehensive Clinical Development

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PATH Vaccine Solutions
• ClinicalTrials.gov Identifier: NCT01537185
• Other Study ID Numbers: VAC 002
• First Posted: Feb 23, 2012
• Last Update Posted: Jun 5, 2014
• Last Verified: Feb 1, 2012

• Additional relevant MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Aluminum sulfate

Study Results

Participant Flow

Arm/Group Title	Cohort 1 SPWCV+Alum 100 mcg	Normal Saline Injection	Cohort 2 SPWCV+Alum 300 mcg	Cohort 3 SPWVC+Alum 600 mcg
Arm/Group Description	each individual receiving 3 vaccinations of same dose 28 days apart	placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection	each individual receiving 3 vaccinations of the same dose 28 days apart	each individual receiving 3 vaccinations of the same dose 28 days apart
Period Title: Overall Study
STARTED	10	12	10	10
COMPLETED	7	6	4	8
NOT COMPLETED	3	6	6	2

Baseline Characteristics

Arm/Group Title	Cohort 1 SPWCV+Alum 100 mcg	Normal Saline Injection	Cohort 2 SPWCV+Alum 300 mcg	Cohort 3 SPWCV+Alum 600 mcg	Total
Arm/Group Description	each individual receiving 3 vaccinations of same dose 28 days apart	placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection	each individual receiving 3 vaccinations of same dose 28 days apart	each individual receiving 3 vaccinations of same dose 28 days apart	Total of all reporting groups
Overall Participants	10	12	10	10	42
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	28.9	28.5	25.2	29.9	28.1
Sex: Female, Male (Count of Participants)
Female	3 30%	8 66.7%	4 40%	7 70%	22 52.4%
Male	7 70%	4 33.3%	6 60%	3 30%	20 47.6%
Region of Enrollment (participants) [Number]
United States	10 100%	12 100%	10 100%	10 100%	42 100%

Outcome Measures

1. Primary Outcome

Title	Unsolicited Adverse Event Reports
Description	Safety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination
Time Frame	within 1 week (0-7 days) following each vaccinations

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1 SPWCV+Alum 100 mcg	Normal Saline Injection	Cohort 2 SPWCV+Alum 300 mcg	Cohort 3 SPWVC+Alum 600 mcg
Arm/Group Description	each individual receiving 3 vaccinations of same dose 28 days apart	placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection	each individual receiving 3 vaccinations of the same dose 28 days apart	each individual receiving 3 vaccinations of the same dose 28 days apart
Measure Participants	10	12	10	10
Number [participants]	7 70%	6 50%	5 50%	6 60%

2. Secondary Outcome

Title	Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG
Description	• Determination of a humoral immune response to whole cell antigen as determined by ELISA of sera collected on Day 0, 28, 56, and 84.
Time Frame	28, 56 and 84 days following initial vaccination

Outcome Measure Data

Analysis Population Description

only subjects with both baseline and day 84 samples were included in the analysis.

Arm/Group Title	Cohort 1 SPWCV+Alum 100 mcg	Normal Saline Injection	Cohort 2 SPWCV+Alum 300 mcg	Cohort 3 SPWVC+Alum 600 mcg
Arm/Group Description	each individual receiving 3 vaccinations of same dose 28 days apart	placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection	each individual receiving 3 vaccinations of same dose 28 days apart	each individual receiving 3 vaccinations of same dose 28 days apart
Measure Participants	9	9	5	9
Number [participants]	0 0%	0 0%	0 0%	1 10%

Adverse Events

Arm/Group Title	Cohort 1 SPWCV+Alum 100 mcg		Normal Saline Injection		Cohort 2 SPWCV+Alum 300 mcg		Cohort 3 SPWCV+Alum 600 mcg
Arm/Group Description	each individual receiving 3 vaccinations of same dose 28 days apart		placebo group within each cohort receive 3 injections of normal saline 28 days apart normal saline injection: 3 cohorts of normal saline injection		each individual receiving 3 vaccinations of same dose 28 days apart		each individual receiving 3 vaccinations of same dose 28 days apart
All Cause Mortality
	Cohort 1 SPWCV+Alum 100 mcg		Normal Saline Injection		Cohort 2 SPWCV+Alum 300 mcg		Cohort 3 SPWCV+Alum 600 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Cohort 1 SPWCV+Alum 100 mcg		Normal Saline Injection		Cohort 2 SPWCV+Alum 300 mcg		Cohort 3 SPWCV+Alum 600 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
Reproductive system and breast disorders
ruptured ectopic pregnancy with hemorrhage	1/10 (10%)	1	0/12 (0%)	0	0/10 (0%)	0	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Cohort 1 SPWCV+Alum 100 mcg		Normal Saline Injection		Cohort 2 SPWCV+Alum 300 mcg		Cohort 3 SPWCV+Alum 600 mcg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/10 (70%)		6/12 (50%)		5/10 (50%)		6/10 (60%)
Blood and lymphatic system disorders
neutropenia	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
Gastrointestinal disorders
diarrhea	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
gastroesophageal reflux disease	0/10 (0%)		1/12 (8.3%)		0/10 (0%)		0/10 (0%)
toothache	0/10 (0%)		1/12 (8.3%)		0/10 (0%)		0/10 (0%)
General disorders
injection site pain	0/10 (0%)		0/12 (0%)		2/10 (20%)		1/10 (10%)
irritability	0/10 (0%)		0/12 (0%)		0/10 (0%)		1/10 (10%)
Infections and infestations
pharyngitis	0/10 (0%)		0/12 (0%)		1/10 (10%)		0/10 (0%)
upper respiratory tract infection	1/10 (10%)		1/12 (8.3%)		0/10 (0%)		0/10 (0%)
viral infection	0/10 (0%)		1/12 (8.3%)		0/10 (0%)		0/10 (0%)
viral upper respiratory tract infection	1/10 (10%)		1/12 (8.3%)		0/10 (0%)		0/10 (0%)
tooth abscess	0/10 (0%)		0/12 (0%)		0/10 (0%)		1/10 (10%)
Injury, poisoning and procedural complications
foot fracture	0/10 (0%)		0/12 (0%)		1/10 (10%)		0/10 (0%)
laceration	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
ligament sprain	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
lip injury	0/10 (0%)		0/12 (0%)		0/10 (0%)		1/10 (10%)
wound	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
sunburn	0/10 (0%)		0/12 (0%)		1/10 (10%)		0/10 (0%)
Investigations
alanine aminotransferase increased	0/10 (0%)		0/12 (0%)		1/10 (10%)		0/10 (0%)
haemoglobin decreased	0/10 (0%)		2/12 (16.7%)		1/10 (10%)		2/10 (20%)
platelet count decreased	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
aspartate aminotransferase increased	0/10 (0%)		0/12 (0%)		1/10 (10%)		0/10 (0%)
Metabolism and nutrition disorders
hyperglycemia	1/10 (10%)		2/12 (16.7%)		0/10 (0%)		0/10 (0%)
Nervous system disorders
headache	0/10 (0%)		0/12 (0%)		0/10 (0%)		2/10 (20%)
Reproductive system and breast disorders
dysfunctional uterine bleeding	0/10 (0%)		0/12 (0%)		0/10 (0%)		1/10 (10%)
dysmenorrhoea	0/10 (0%)		0/12 (0%)		1/10 (10%)		0/10 (0%)
Respiratory, thoracic and mediastinal disorders
nasal congestion	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
rhinitis allergic	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
sinus congestion	1/10 (10%)		0/12 (0%)		0/10 (0%)		0/10 (0%)
wheezing	0/10 (0%)		1/12 (8.3%)		0/10 (0%)		0/10 (0%)
Skin and subcutaneous tissue disorders
alopecia	0/10 (0%)		1/12 (8.3%)		0/10 (0%)		0/10 (0%)
ecchymosis	1/10 (10%)		0/12 (0%)		0/10 (0%)		1/10 (10%)
night sweats	0/10 (0%)		0/12 (0%)		0/10 (0%)		1/10 (10%)
skin ulcer	0/10 (0%)		1/12 (8.3%)		0/10 (0%)		0/10 (0%)
Surgical and medical procedures
Endodontic Procedure	0/10 (0%)		0/12 (0%)		0/10 (0%)		1/10 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.