A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Monovalent Influenza A (H1N1) Vaccine in HIV-1 Infected Pregnant Women
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 130
- Locations
- 31
- Primary Endpoint
- The Number of Participants Who Had at Least One Adverse Event (AE)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza vaccine in pregnant women infected with HIV.
Detailed Description
On June 11, 2009, the World Health Organization declared a pandemic of the new H1N1 influenza virus, after the virus had caused significant fevers and respiratory illnesses in Mexico and the United States. Pregnant women are at an increased risk of complications from influenza. HIV infected people tend to have lower than normal antibody responses to seasonal influenza vaccines. Data suggest that larger than average doses of a vaccine counteract a weak antibody response. Preliminary results from ongoing studies of influenza A (H1N1) 2009 monovalent vaccines indicate that the vaccine may increase immune activation. This study tested the safety and antibody response of high doses of the influenza A (H1N1) 2009 monovalent vaccine in pregnant women infected with HIV. Participation in this study lasted until 6 months after participants had delivered their babies or up to 52 weeks. Participants received two doses of the H1N1 vaccine at study entry and after 21 days. Each dose consisted of two intramuscular injections (four total injections). On the days of the injections, participants had their babies' heart rates checked before and after vaccination. At these visits, and at follow-up visits on Days 21, 31, and 42, participants completed a review of symptoms, physical and neurological exams, and a blood draw. For 10 days after receiving each dose of the vaccine, participants were asked to keep track of their temperatures and symptoms or reactions in a journal. Participants were contacted on Day 2 and Day 10 after the first dose of vaccine was given and on Day 2 after the second dose of vaccine was given. Some participants also received a phone call after 6 months. At delivery of each participant's baby, blood was drawn from both the mother and umbilical cord (or from the baby if the cord blood could not be obtained). At 3 and 6 months after delivery, participants came in for follow-up visits involving, for both mother and child, a review of symptoms, brief physical exams, and blood draws (at 6 months only some women had a clinic visit, the rest received a phone call).
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 6 months after delivery
Shows the number of participants who had at least one adverse event (AE) in each category. These 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.
The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
Time Frame: Measured up to 6 months after delivery
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
Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40
Time Frame: Measured at 21 days after first dose and at 10 days after second dose of study vaccine
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.
Secondary Outcomes
- Infant GMT of Antibodies HAI(Measured at birth and at 3 and 6 months of age)
- Percent of Infants With an HAI Titer of >= 40(Measured at birth (via cord blood) and at 3 months and 6 months of age)
- Maternal Cell-mediated Immunity (CMI) Responses, as Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values(Measured at entry, at 21 days after first dose of vaccine, at 10 days after second dose)
- Response to Seasonal Trivalent Influenza Vaccine (TIV)(Measured at entry)
- Percent of Pregnant Women With an HAI Titer of >= 40 at Delivery, 3 Months and 6 Months After Delivery(Measured at delivery of the baby, and at 3 months and 6 months after delivery)
- Maternal Geometric Mean Titers (GMT) of Antibodies HAI(Measured after the first and second doses of the vaccine, at delivery, and at 3 and 6 months after delivery)