Trial · NCT02968849
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment | Measured through 24 months after first vaccination | Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test. |
| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 3 full days following each vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 3 full days following each vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Primary | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 3 full days following each vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented. |
| Primary | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Measured through 30 days after each vaccination | For participants reporting multiple AEs over the time frame, the maximum relationship is counted. |
| Primary | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Measured through 30 days after each vaccination | For participants reporting multiple AEs over the time frame, the maximum severity grade is counted. |
| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) | Measured through 12 months after last vaccination | Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual). |
| Primary | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | Measured through 12 months after last vaccination | Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases. |
| Primary | Number of Participants Reporting New Chronic Medical Conditions | Measured through 12 months after last vaccination | A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days. |
| Primary | Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest) | From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group. |
| Primary | Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest) | From the study product discontinuation form, study product discontinuation reasons are tabulated by treatment group. |
| Primary | Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up | Measured through 36 months after first vaccination | Per the 23 January 2020 DSMB finding that monitoring boundaries for non-efficacy have been met, Primary outcome 1 has been superseded by this primary outcome. Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test. |
| Secondary | Incidence Rate of HIV-1 Infection Diagnosed After Enrollment Through 36 Months Post Enrollment | Measured through 36 months after first vaccination | This outcome measure is the same as Primary Outcome 12, which was added after pre-established criteria for vaccine non-efficacy had been met. Analysis was not repeated but the outcome is listed for completeness. |
| Secondary | Incidence Rate of HIV-1 Infection Diagnosed After Month 6.5 Through 24 Months Post Enrollment | Measured after Month 6.5 through 24 months after first vaccination | Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test. |
| Secondary | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | Measured at Month 6.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. |
| Secondary | Number of Participants With Occurrence of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | Measured at Month 6.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). One-sided Fisher's exact test is applied, testing if number of cells positive for the marker is equal in stimulated vs. unstimulated cells. Bonferroni-Holm adjustment is made over peptide pools. Response is positive if adjusted p-value le 0.00001. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. |
| Secondary | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 in Response to HIV Proteins Included in the Vaccine at Month 6.5 | Measured at Month 6.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only. |
| Secondary | Level of CD4+ and CD8+ T-Cells Expressing IFN-g and/or IL-2 and/or CD40L in Response to HIV Proteins Included in the Vaccine at Month 6.5 | Measured at Month 6.5 | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as negative control. Response magnitude is % cells expressing IFN-g and/or IL-2 after stimulation minus % cells expressing markers after no stimulation. Data are excluded if blood draw date was outside visit window, participant was HIV-infected (post-infection samples), PBMC viability/T-cell count were low or negative control was high. Any Env is the maximum of ZM96 gp120, 1086 gp120, and TV1 gp120. Any HIV is the sum of Any Env and LAI Gag. Negative magnitudes are censored at 0 before calculating sum; if the sum is lt 0.01, it is set to 0.01%. Summary was calculated among positive responders only. |
| Secondary | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay, run at 1:50 dilution.The readout is background-subtracted mean fluorescent intensity(MFI),with background adjustment for an antigen-specific plate level control.For each sample,response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI. Net MFI lt 1 is set to 1,and net MFI \> 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen \> 5,000 MFI or baseline net MFI \> 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI),(2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. |
| Secondary | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | Serum IgG3 responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay,run at 1:40 dilution.The readout is background-subtracted mean fluorescent intensity(MFI), with background adjustment for an antigen-specific plate level control.For each sample, response magnitude is net MFI,defined as experimental antigen MFI minus reference antigen MFI.Net MFI lt 1 is set to 1, and net MFI \> 22,000 is set to 22,000.Data are excluded if blood draw date was outside the allowable window,a participant was HIV-infected,reference antigen \> 5,000 MFI or baseline net MFI \> 6,500.Samples from post-enrollment visits have positive responses if they meet three criteria:(1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline M |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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