Safety of and Immune Response to Two Influenza Vaccines in HIV Infected Children and Adolescents

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00091702
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 300
• Locations: 61
• Patients Per Site: 4.9

Study Details

Study Description

Brief Summary

The purpose of this study is to compare two flu vaccines to determine their safety and ability to stimulate an immune response in HIV infected children and adolescents. This study will also determine how often and how long people who receive a vaccine are able to spread flu vaccine virus to other people.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Influenza	Biological: Cold-adapted live attenuated influenza vaccine (FluMist); Biological: Inactivated influenza vaccine (IAIV)	Phase 1/Phase 2

Detailed Description

Influenza virus infections are common among children, particularly during the winter season. The infections are often mild, but more serious cases can cause a number of complications, including respiratory illnesses and bacterial infections. HIV infected children may have an increased risk for developing influenza-related bacterial complications, and influenza infections among this population may lead to more rapid disease progression. The current standard of care for HIV infected children is vaccination with an inactivated influenza vaccine (IAIV). However, IAIV is limited in its ability to stimulate the immune systems of HIV infected children with advanced disease. FluMist, a cold-adapted live attenuated influenza vaccine, is both immunogenic and effective in HIV infected children; unfortunately, FluMist is associated with viral shedding, a period of time when the influenza virus used to produce the vaccine may be transmitted to other people. This study will compare the safety and immunogenicity of IAIV and FluMist in HIV infected children and adolescents. This study will also determine the prevalence and duration of FluMist viral shedding in HIV infected children and adolescents who have received the vaccination.

Participants in this study will be randomly assigned to one of two arms. Arm A participants will receive FluMist; Arm B participants will receive IAIV. A single immunization will occur on Day 0 of the study. Arm A participants will have study visits on Days 3, 14, and 28 or home visits on Days 3 and 14. Participants in Arm B will have a study visit on Day 28. A physical exam will be performed at the initial study visit; blood will be collected at study start and at each visit thereafter. Phone calls will be made to participants throughout the study. All participants will have a final study visit after 6 months.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Prevention
• Official Title: A Phase I/II Randomized Trial of the Safety and Immunogenicity of Cold Adapted Influenza Vaccine (FluMist) in HIV-Infected Children and Adolescents
• Actual Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• HIV infected

• Stable highly active antiretroviral therapy (HAART) regimen for at least 16 weeks with no changes in therapy anticipated

• Meet certain CD4 cell count and CD4% requirements

• Viral load of less than 60,000 copies/ml within 60 days prior to study start

• Received inactivated influenza vaccine (IAIV) in at least one of the past 2 years

• Written informed consent of parent or legal guardian

• Availability of parent or legal guardian to be contacted by phone

Exclusion Criteria:

• Immunosuppressive or immunomodulatory therapy within 60 days prior to immunization or immunological testing

• Aspirin or aspirin-containing therapy at the time of vaccination or planned within 42 days after immunization

• History of hypersensitivity to any component of IAIV or FluMist

• History of Guillain-Barre syndrome

• Receipt of any inactivated vaccine within 14 days prior to the study vaccination

• Receipt of any live vaccine within 30 days prior to the study vaccination

• Plans to receive any vaccine within the 30 days following the vaccination

• Receipt of any additional influenza vaccine for the duration of the study

• Prophylactic use of drugs with anti-influenza activity

• Moderate chronic pulmonary disease, obstructive or restrictive

• Cardiopulmonary disease affecting normal childhood activity

• Medically-diagnosed wheezing, bronchodilator use, or steroid use within the past 42 days

• Medical illness associated with suppression of T-cell immunity

• Pregnancy, breast-feeding, or unwillingness to use acceptable methods of contraception for 3 months following vaccination

• Severely immunosuppressed household member

• Receipt of any blood products within 3 months prior to vaccination or expected receipt during the study, including the 6-month follow-up period

• Significant fever or illness within 72 hours prior to vaccination

• Any other condition that would interfere with the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB, Dept. of Ped., Div. of Infectious Diseases	Birmingham	Alabama	United States	35233
2	Univ. of South Alabama College of Medicine, Southeast Ped. ACTU	Mobile	Alabama	United States
3	Phoenix Children's Hosp.	Phoenix	Arizona	United States	85006
4	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California	United States	90801
5	Usc La Nichd Crs	Los Angeles	California	United States	90033
6	UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS	Los Angeles	California	United States
7	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California	United States	94609-1809
8	Children's Hosp. of Orange County	Orange	California	United States	92868
9	UCSD Maternal, Child, and Adolescent HIV CRS	San Diego	California	United States	92103
10	UCSF Pediatric AIDS CRS	San Francisco	California	United States	94143-0105
11	Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases	Torrance	California	United States	90509
12	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado	United States
13	Connecticut Children's Med. Ctr.	Hartford	Connecticut	United States
14	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut	United States	06504
15	Children's National Med. Ctr. Washington DC NICHD CRS	Washington	District of Columbia	United States	20010
16	Children's National Med. Ctr., ACTU	Washington	District of Columbia	United States	20010
17	Howard Univ. Washington DC NICHD CRS	Washington	District of Columbia	United States	20060
18	South Florida CDC Ft Lauderdale NICHD CRS	Fort Lauderdale	Florida	United States	33316
19	Children's Diagnostic & Treatment Ctr. of South Florida	Fort Lauderdale	Florida	United States
20	Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy	Gainesville	Florida	United States	32610-0296
21	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida	United States	32209
22	Univ. of Miami Ped. Perinatal HIV/AIDS CRS	Miami	Florida	United States	33136
23	USF - Tampa NICHD CRS	Tampa	Florida	United States	33620
24	Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases	Augusta	Georgia	United States
25	Columbus Regional HealthCare System, The Med. Ctr.	Columbus	Georgia	United States	31901
26	Chicago Children's CRS	Chicago	Illinois	United States	60614
27	Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program	Chicago	Illinois	United States
28	Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease	Chicago	Illinois	United States
29	Tulane/LSU Maternal/Child CRS	New Orleans	Louisiana	United States	70112-2699
30	Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases	Baltimore	Maryland	United States
31	Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology	Baltimore	Maryland	United States
32	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts	United States	02115
33	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts	United States	02118
34	Lawrence Family Health Ctr., Essex St. Clinic	Lawrence	Massachusetts	United States	01841-2884
35	Lowell Community Health Ctr.	Lowell	Massachusetts	United States	01854
36	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts	United States	01199
37	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts	United States
38	Children's Hospital of Michigan NICHD CRS	Detroit	Michigan	United States	48201
39	Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.	Saint Louis	Missouri	United States	63110
40	NJ Med. School CRS	Newark	New Jersey	United States
41	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York	United States	10457
42	Jacobi Med. Ctr. Bronx NICHD CRS	Bronx	New York	United States	10461
43	Jacobi Med. Ctr.	Bronx	New York	United States	10461
44	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York	United States	11203-2098
45	Nyu Ny Nichd Crs	New York	New York	United States	10016
46	Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases	New York	New York	United States	10029
47	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York	United States	10037
48	Columbia IMPAACT CRS	New York	New York	United States
49	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York	United States	14642
50	SUNY Stony Brook NICHD CRS	Stony Brook	New York	United States	11794-8111
51	SUNY Upstate Med. Univ., Dept. of Peds.	Syracuse	New York	United States	13210
52	UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases	Chapel Hill	North Carolina	United States	27599-7220
53	DUMC Ped. CRS	Durham	North Carolina	United States	27705
54	The Children's Hosp. of Philadelphia IMPAACT CRS	Philadelphia	Pennsylvania	United States	19104-4318
55	St. Jude/UTHSC CRS	Memphis	Tennessee	United States	38105-2794
56	Texas Children's Hosp. CRS	Houston	Texas	United States	77030
57	Children's Hosp. of the King's Daughters, Infectious Disease	Norfolk	Virginia	United States	23507
58	Seattle Children's Hospital CRS	Seattle	Washington	United States	98105-0371
59	UW School of Medicine - CHRMC	Seattle	Washington	United States	98105
60	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan		Puerto Rico	00936-5067
61	San Juan City Hosp. PR NICHD CRS	San Juan		Puerto Rico

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Study Chair: Myron J. Levin, MD, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Haga clic aquí para ver información sobre este ensayo clínico en español.

Publications

• Belshe RB, Mendelman PM, Treanor J, King J, Gruber WC, Piedra P, Bernstein DI, Hayden FG, Kotloff K, Zangwill K, Iacuzio D, Wolff M. The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998 May 14;338(20):1405-12.
• Günthard HF, Wong JK, Spina CA, Ignacio C, Kwok S, Christopherson C, Hwang J, Haubrich R, Havlir D, Richman DD. Effect of influenza vaccination on viral replication and immune response in persons infected with human immunodeficiency virus receiving potent antiretroviral therapy. J Infect Dis. 2000 Feb;181(2):522-31.
• King JC Jr, Fast PE, Zangwill KM, Weinberg GA, Wolff M, Yan L, Newman F, Belshe RB, Kovacs A, Deville JG, Jelonek M; HIV Influenza Study Group. Safety, vaccine virus shedding and immunogenicity of trivalent, cold-adapted, live attenuated influenza vaccine administered to human immunodeficiency virus-infected and noninfected children. Pediatr Infect Dis J. 2001 Dec;20(12):1124-31.
• King JC Jr, Treanor J, Fast PE, Wolff M, Yan L, Iacuzio D, Readmond B, O'Brien D, Mallon K, Highsmith WE, Lambert JS, Belshe RB. Comparison of the safety, vaccine virus shedding, and immunogenicity of influenza virus vaccine, trivalent, types A and B, live cold-adapted, administered to human immunodeficiency virus (HIV)-infected and non-HIV-infected adults. J Infect Dis. 2000 Feb;181(2):725-8.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT00091702
• Other Study ID Numbers: P1057; 10612; PACTG P1057
• First Posted: Sep 20, 2004
• Last Update Posted: Nov 1, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID): FluMist; Influenza Vaccine; Adolescent; Treatment Experienced
• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

No Results Posted as of Nov 1, 2021