Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women
- Conditions
- HIV InfectionsH1N1 Influenza Virus
- Interventions
- Biological: Influenza A (H1N1) monovalent vaccine
- Registration Number
- NCT00992017
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description H1N1 vaccine Influenza A (H1N1) monovalent vaccine Pregnant women enrolled received two doses of H1N1 vaccine, administered 21 days apart.
- Primary Outcome Measures
Name Time Method The Number of Participants Who Had at Least One Adverse Event (AE) 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 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 Measured at Day 21 Percent of Pregnant Women With a Hemagglutination Inhibition (HAI) Titer of >= 40 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 Outcome Measures
Name Time Method Infant GMT of Antibodies HAI Measured at birth and at 3 and 6 months of age Presents the value of the geometric mean titer at each time point. 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.
Percent of Infants With an HAI Titer of >= 40 Measured at birth (via cord blood) and at 3 months and 6 months of age 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.
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 The median and interquartile range (IQR) of B-Cell ELISPOT-measured IgG antibody-secreting cells (ASC)/10\^6 PBMC and the median and interquartile range (IQR) of T-Cell ELISPOT-measured pH1N1 IFNgamma spot-forming cells (SFC)/10\^6 PBMC.
Response to Seasonal Trivalent Influenza Vaccine (TIV) Measured at entry 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 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 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.
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 Presents the value of the geometric mean titer at each time point. 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.
Trial Locations
- Locations (31)
University of California, UC San Diego CRS
🇺🇸La Jolla, California, United States
Usc La Nichd Crs
🇺🇸Alhambra, California, United States
Washington Hosp. Ctr. NICHD CRS
🇺🇸Washington, District of Columbia, United States
Miller Children's Hosp. Long Beach CA NICHD CRS
🇺🇸Long Beach, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
🇺🇸Los Angeles, California, United States
Univ. of Colorado Denver NICHD CRS
🇺🇸Aurora, Colorado, United States
South Florida CDTC Ft Lauderdale NICHD CRS
🇺🇸Fort Lauderdale, Florida, United States
USF - Tampa NICHD CRS
🇺🇸Tampa, Florida, United States
Univ. of Florida Jacksonville NICHD CRS
🇺🇸Jacksonville, Florida, United States
Ann & Robert H. Lurie Children's Hospital of Chicago (LCH) CRS
🇺🇸Chicago, Illinois, United States
Tulane Univ. New Orleans NICHD CRS
🇺🇸New Orleans, Louisiana, United States
WNE Maternal Pediatric Adolescent AIDS CRS
🇺🇸Worcester, Massachusetts, United States
Rutgers - New Jersey Medical School CRS
🇺🇸Newark, New Jersey, United States
Bronx-Lebanon CRS
🇺🇸Bronx, New York, United States
Jacobi Med. Ctr. Bronx NICHD CRS
🇺🇸Bronx, New York, United States
Metropolitan Hosp. NICHD CRS
🇺🇸New York, New York, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
St. Jude Children's Research Hospital CRS
🇺🇸Memphis, Tennessee, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
🇺🇸Philadelphia, Pennsylvania, United States
University of Puerto Rico Pediatric HIV/AIDS Research Program CRS
🇵🇷San Juan, Puerto Rico
San Juan City Hosp. PR NICHD CRS
🇵🇷San Juan, Puerto Rico
Rush Univ. Cook County Hosp. Chicago NICHD CRS
🇺🇸Chicago, Illinois, United States
Seattle Children's Research Institute CRS
🇺🇸Seattle, Washington, United States
Children's Hosp. of Boston NICHD CRS
🇺🇸Boston, Massachusetts, United States
Boston Medical Center Ped. HIV Program NICHD CRS
🇺🇸Boston, Massachusetts, United States
Johns Hopkins Univ. Baltimore NICHD CRS
🇺🇸Baltimore, Maryland, United States
Pediatric Perinatal HIV Clinical Trials Unit CRS
🇺🇸Miami, Florida, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States
Texas Children's Hospital CRS
🇺🇸Houston, Texas, United States
Univ. of California San Francisco NICHD CRS
🇺🇸San Francisco, California, United States