Safety of & Immune Response to Two Influenza Vaccines in NCT00091702

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT00091702
Other study ID #	P1057
Secondary ID	10612PACTG P1057
Status	Completed
Phase	Phase 1/Phase 2
First received
Last updated
Est. completion date	January 2006

Study information
Verified date	October 2021
Source	National Institute of Allergy and Infectious Diseases (NIAID)
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status	Completed
Enrollment	300
Est. completion date	January 2006
Est. primary completion date
Accepts healthy volunteers	No
Gender	All
Age group	5 Years to 17 Years
Eligibility	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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Cold-adapted live attenuated influenza vaccine (FluMist)

• Inactivated influenza vaccine (IAIV)

Locations
Country	Name	City	State
Puerto Rico	San Juan City Hosp. PR NICHD CRS	San Juan
Puerto Rico	Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS	San Juan
United States	Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases	Augusta	Georgia
United States	Univ. of Colorado Denver NICHD CRS	Aurora	Colorado
United States	Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases	Baltimore	Maryland
United States	Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology	Baltimore	Maryland
United States	UAB, Dept. of Ped., Div. of Infectious Diseases	Birmingham	Alabama
United States	BMC, Div. of Ped Infectious Diseases	Boston	Massachusetts
United States	HMS - Children's Hosp. Boston, Div. of Infectious Diseases	Boston	Massachusetts
United States	Bronx-Lebanon Hosp. IMPAACT CRS	Bronx	New York
United States	Jacobi Med. Ctr.	Bronx	New York
United States	Jacobi Med. Ctr. Bronx NICHD CRS	Bronx	New York
United States	SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS	Brooklyn	New York
United States	UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases	Chapel Hill	North Carolina
United States	Chicago Children's CRS	Chicago	Illinois
United States	Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program	Chicago	Illinois
United States	Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease	Chicago	Illinois
United States	Columbus Regional HealthCare System, The Med. Ctr.	Columbus	Georgia
United States	Children's Hospital of Michigan NICHD CRS	Detroit	Michigan
United States	DUMC Ped. CRS	Durham	North Carolina
United States	Children's Diagnostic & Treatment Ctr. of South Florida	Fort Lauderdale	Florida
United States	South Florida CDC Ft Lauderdale NICHD CRS	Fort Lauderdale	Florida
United States	Univ. of Florida College of Medicine-Dept of Peds, Div. of Immunology, Infectious Diseases & Allergy	Gainesville	Florida
United States	Connecticut Children's Med. Ctr.	Hartford	Connecticut
United States	Texas Children's Hosp. CRS	Houston	Texas
United States	Univ. of Florida Jacksonville NICHD CRS	Jacksonville	Florida
United States	Lawrence Family Health Ctr., Essex St. Clinic	Lawrence	Massachusetts
United States	Long Beach Memorial Med. Ctr., Miller Children's Hosp.	Long Beach	California
United States	UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS	Los Angeles	California
United States	Usc La Nichd Crs	Los Angeles	California
United States	Lowell Community Health Ctr.	Lowell	Massachusetts
United States	St. Jude/UTHSC CRS	Memphis	Tennessee
United States	Univ. of Miami Ped. Perinatal HIV/AIDS CRS	Miami	Florida
United States	Univ. of South Alabama College of Medicine, Southeast Ped. ACTU	Mobile	Alabama
United States	Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease	New Haven	Connecticut
United States	Tulane/LSU Maternal/Child CRS	New Orleans	Louisiana
United States	Columbia IMPAACT CRS	New York	New York
United States	Harlem Hosp. Ctr. NY NICHD CRS	New York	New York
United States	Mt. Sinai School of Medicine, Div. of Ped. Infectious Diseases	New York	New York
United States	Nyu Ny Nichd Crs	New York	New York
United States	NJ Med. School CRS	Newark	New Jersey
United States	Children's Hosp. of the King's Daughters, Infectious Disease	Norfolk	Virginia
United States	Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.	Oakland	California
United States	Children's Hosp. of Orange County	Orange	California
United States	The Children's Hosp. of Philadelphia IMPAACT CRS	Philadelphia	Pennsylvania
United States	Phoenix Children's Hosp.	Phoenix	Arizona
United States	Strong Memorial Hospital Rochester NY NICHD CRS	Rochester	New York
United States	Washington Univ. School of Medicine at St. Louis, St. Louis Children's Hosp.	Saint Louis	Missouri
United States	UCSD Maternal, Child, and Adolescent HIV CRS	San Diego	California
United States	UCSF Pediatric AIDS CRS	San Francisco	California
United States	Seattle Children's Hospital CRS	Seattle	Washington
United States	UW School of Medicine - CHRMC	Seattle	Washington
United States	Baystate Health, Baystate Med. Ctr.	Springfield	Massachusetts
United States	SUNY Stony Brook NICHD CRS	Stony Brook	New York
United States	SUNY Upstate Med. Univ., Dept. of Peds.	Syracuse	New York
United States	USF - Tampa NICHD CRS	Tampa	Florida
United States	Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases	Torrance	California
United States	Children's National Med. Ctr. Washington DC NICHD CRS	Washington	District of Columbia
United States	Children's National Med. Ctr., ACTU	Washington	District of Columbia
United States	Howard Univ. Washington DC NICHD CRS	Washington	District of Columbia
United States	WNE Maternal Pediatric Adolescent AIDS CRS	Worcester	Massachusetts

Sponsors *(2)*
Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Countries where clinical trial is conducted

United States, Puerto Rico,

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Weinberg A, Song LY, Walker R, Allende M, Fenton T, Patterson-Bartlett J, Nachman S, Kemble G, Yi TT, Defechereux P, Wara D, Read JS, Levin M; IMPAACT P1057 Team. Anti-influenza serum and mucosal antibody responses after administration of live attenuated — View Citation

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External Links

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

Clinical Trial Details — Status: Completed

Administrative data

Study information