H1N1 Vaccine at Two Dose Levels in HIV Positive Adults
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00992433
First received: October 8, 2009
Last updated: May 10, 2012
Last verified: February 2011
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Results First Received: October 13, 2011
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention |
| Condition: |
Influenza |
| Intervention: |
Biological: Inactivated Influenza H1N1 vaccine |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were HIV-positive adult males and females recruited from existing patient populations and from the communities at large around the clinical sites. Participants were enrolled between 19Nov2009 and 23Apr2010. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| 15 Mcg H1N1 Vaccine | 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21. |
| 30 Mcg H1N1 Vaccine | 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21. |
Participant Flow: Overall Study
| 15 Mcg H1N1 Vaccine | 30 Mcg H1N1 Vaccine | |
|---|---|---|
| STARTED | 95 | 97 |
| COMPLETED | 91 | 90 |
| NOT COMPLETED | 4 | 7 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 15 Mcg H1N1 Vaccine | 15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21. |
| 30 Mcg H1N1 Vaccine | 30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21. |
| Total | Total of all reporting groups |
Baseline Measures
| 15 Mcg H1N1 Vaccine | 30 Mcg H1N1 Vaccine | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
95 | 97 | 192 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 95 | 97 | 192 |
| >=65 years | 0 | 0 | 0 |
|
Age
[units: years] Mean ± Standard Deviation |
45.7 ± 9.9 | 45.3 ± 9.3 | 45.5 ± 9.6 |
|
Gender
[units: participants] |
|||
| Female | 19 | 22 | 41 |
| Male | 76 | 75 | 151 |
|
Region of Enrollment
[units: participants] |
|||
| United States | 95 | 97 | 192 |
Outcome Measures
| 1. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ] |
| 2. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the first vaccination ] |
| 3. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 10 days after the second vaccination ] |
| 4. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the second vaccination ] |
| 5. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 180 days after the second vaccination ] |
| 6. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ] |
| 7. Primary: | Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the first vaccination ] |
| 8. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 10 days after the second vaccination ] |
| 9. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 21 days after the second vaccination ] |
| 10. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 180 days after the second vaccination ] |
| 11. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and 10 days after the first vaccination ] |
| 12. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 21 after the first vaccination ] |
| 13. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 10 after the second vaccination ] |
| 14. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ] |
| 15. Primary: | Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 180 after the second vaccination ] |
| 16. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to the first vaccination ] |
| 17. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 10 after the first vaccination ] |
| 18. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine [ Time Frame: Day 21 after the first vaccination ] |
| 19. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 10 and Day 21 after the second vaccination ] |
| 20. Primary: | Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 180 after the second vaccination ] |
| 21. Primary: | Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination [ Time Frame: Within 8 days post first vaccination (Day 0-7). ] |
| 22. Primary: | Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination [ Time Frame: Within 8 days post second vaccination (Day 0-7). ] |
| 23. Primary: | Number of Participants Reporting Fever After the First Vaccination [ Time Frame: Within 8 days post first vaccination (Day 0-7). ] |
| 24. Primary: | Number of Participants Reporting Fever After the Second Vaccination [ Time Frame: Within 8 days post second vaccination (Day 0-7). ] |
| 25. Primary: | Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination [ Time Frame: Within 8 days post first vaccination (Day 0-7). ] |
| 26. Primary: | Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination [ Time Frame: Within 8 days post second vaccination (Day 0-7). ] |
| 27. Primary: | Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination [ Time Frame: Within 8 days post first vaccination (Day 0-7). ] |
| 28. Primary: | Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination [ Time Frame: Within 8 days post second vaccination (Day 0-7). ] |
| 29. Primary: | Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs) [ Time Frame: Day 0 through Day 180 after the last vaccination ] |