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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
155
Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections
The Number of Participants Who Had at Least One Adverse Event (AE)
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.
Time frame: Measured up to 7 months after vaccination
The Number of Participants Who Had at Least One AE Attributed to the Study Vaccine
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.
Time frame: Measured up to 7 months after vaccination
Withholding of Second Vaccine Dose Due to Adverse Reactions Attributed to First Dose
Time frame: Measured at Day 21
Percent of Participants With a Hemagglutinin Inhibition (HAI) Titer of >=40
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.
Time frame: Measured at 21 days after first dose and 10 days after second dose
Percent of Participants With an HAI Titer >=40 at Long-term Follow-up
Time frame: Measured at 6 months after second dose
Geometric Mean Antibody Titers (GMT) HAI
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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
Long Beach, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Univ. of California San Francisco NICHD CRS
San Francisco, California, United States
Harbor UCLA Medical Ctr. NICHD CRS
Torrance, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
...and 27 more locations
Presents the value of the geometric mean titer at each time point.
Time frame: Measured after first and second doses and 6 months after second dose
Cell-mediated Immune Responses, Measured by B-cell and T-cell Enzyme-linked Immunosorbent Spot (ELISPOT) Assay Values
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.
Time frame: 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)
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.
Time frame: Measured at entry, 21 days after first dose, and 10 days and 6 months after second dose
Cell-mediated Immune Responses to Influenza Viruses Contained in TIV and Other Antigens
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.
Time frame: Measured at entry, 21 days after first dose, and 10 days after second dose