A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Perinatally Infected Children and Youth
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 155
- Locations
- 37
- Primary Endpoint
- The Number of Participants Who Had at Least One Adverse Event (AE)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The Number of Participants Who Had at Least One Adverse Event (AE)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Measured at Day 21
Secondary Outcomes
- 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)
- 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)
- 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)
- 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)