Safety of and Immune Response to an H1N1 Influenza Virus Vaccine in HIV Infected Children and Youth

Phase 2

Completed

Conditions: HIV Infections
H1N1 Influenza Virus

Registration Number: NCT00992836

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary: Children and people infected with HIV are particularly susceptible to influenza infections. This study testED the safety and effectiveness of a vaccine for the new H1N1 influenza virus in children and youth infected with HIV.

Detailed Description: The new H1N1 influenza virus seen in 2009 has been designated a pandemic by the World Health Organization, due to the sustained community outbreaks seen in the United States and Mexico. Based on preliminary data, it appears children and young adults were particularly at risk of the H1N1 virus. People infected with HIV were also more susceptible to severe influenza infections than those who are uninfected. Children with HIV infection, then, have a compounded risk of H1N1 infection. Higher doses of influenza vaccines are associated with the development of higher levels of serum antibodies, which are needed to resist infection. Higher vaccine doses can be used to improve vaccine effectiveness in at-risk populations. This study tested the safety and immune response of HIV infected children and youth to a high dose of a vaccine for the new H1N1 influenza virus.

Participation in this study lasted 7 months and had two steps. The first step involved receiving the first dose of H1N1 virus vaccine, and the second step, occurring 21 days later, involved receiving the second dose of vaccine. Each dose of vaccine was delivered via two intramuscular shots (four total injections). After receiving each dose of the vaccine, participants were given a diary to record any symptoms or reactions. Participants were stratified into three groups by age, including 4 to 9 years, 9 to 18 years, and 18 to 25 years.

Participants completed five scheduled visits, taking place at screening, study entry, Days 21 and 31, and after 7 months. Measurements taken on these visits included a medical history, physical and neurological exams, a blood draw, and, when applicable, a pregnancy test. In addition to these visits, participants received up to three additional phone calls or visits occurring 2 and 10 days after the first dose of vaccine and 2 days after the second dose of vaccine to check for reactions to the vaccine.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 155

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Number of Participants Who Had at Least One Adverse Event (AE)	Measured up to 7 months after vaccination	Shows the number of participants who had at least one adverse event (AE) in each category. The AEs include: abnormal laboratory values, signs and symptoms, or diagnoses; solicited local AEs; and solicited systemic AEs. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40	Measured at 21 days after first dose and 10 days after second dose	Antibodies to Influenza A (H1N1) 2009 were measured using an HAI assay. The potential titer read-outs from the assay used were \<10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640 and \>=1280. Seroprotection was defined as having a titer of \>=40 following vaccination.
The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine	Measured up to 7 months after vaccination	Shows the number of participants who experienced any events that were thought to be at least possibly related to study treatment. Adverse Events were graded using the DAIDS Grading Severity of AEs (see Link under More Information), as follows: grade 1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death.
Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose	Measured at Day 21

Secondary Outcome Measures

Name	Time	Method
Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values	Measured at entry, 21 days after first dose, and 10 days after second dose	The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10\^6 peripheral blood mononucleated cell (PBMC) and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10\^6 PBMC.
HAI Titers Against Seasonal Influenza Viruses Containing Trivalent Influenza Vaccine (TIV)	Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose	Presents the value of the median titer as well as the interquartile range at study entry. Antibodies to seasonal Influenza vaccine were measured using an HAI assay. The potential titer read-outs from the assay used were \<10 (considered undetectable), 10, 20, 40, 60, 80, 160, 320, 640, and \>=1280.
Percent of Participants With an HAI Titer >=40 at Long-term Follow-up	Measured at 6 months after second dose
Geometric Mean Antibody Titers (GMT) HAI	Measured after first and second doses and 6 months after second dose	Presents the value of the geometric mean titer at each time point.
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens	Measured at entry, 21 days after first dose, and 10 days after second dose	The TIV assay was not performed due to lack of available cells after completion of other planned assays. The median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 Granzyme B spot-forming cells (SFC)/10\^6 peripheral blood mononucleated cell (PBMC). The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA INFgamma spot-forming cells (SFC)/10\^6 PBMC. The median and interquartile range (IQR) of T-Cell ELISPOT-measured PHA Granzyme B spot-forming cells (SFC)/10\^6 PBMC.

Trial Locations

Locations (37): UAB Pediatric Infectious Diseases CRS
🇺🇸
Birmingham, Alabama, United States
Usc La Nichd Crs
🇺🇸
Alhambra, California, United States
University of California, UC San Diego CRS
🇺🇸
La Jolla, California, United States
Miller Children's Hosp. Long Beach CA NICHD CRS
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Long Beach, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
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Los Angeles, California, United States
Univ. of California San Francisco NICHD CRS
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San Francisco, California, United States
Harbor UCLA Medical Ctr. NICHD CRS
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Torrance, California, United States
Univ. of Colorado Denver NICHD CRS
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Aurora, Colorado, United States
Children's National Med. Ctr. Washington DC NICHD CRS
🇺🇸
Washington, District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
🇺🇸
Washington, District of Columbia, United States
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UAB Pediatric Infectious Diseases CRS
🇺🇸Birmingham, Alabama, United States