Trial · NCT02968849
Outcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | MITT cohort | events per 100 person-years | NUMBER |
| PRIMARY | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 3 full days following each vaccination | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 3 full days following each vaccination | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Measured through 3 full days following each vaccination | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product | Measured through 30 days after each vaccination | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Adverse Events (AEs), by Severity Grade | Measured through 30 days after each vaccination | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Serious Adverse Events (SAEs) | Measured through 12 months after last vaccination | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting Adverse Events of Special Interest (AESIs) | Measured through 12 months after last vaccination | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Reporting New Chronic Medical Conditions | Measured through 12 months after last vaccination | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Safety cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Incidence Rate of HIV-1 Infections Diagnosed Following Enrollment and Throughout All Participant Follow-Up | Measured through 36 months after first vaccination | MITT cohort | events per 100 person-years | NUMBER |
| 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 | Week 26 at-risk cohort | events per 100 person-years | NUMBER |
| 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 | Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria. | % T-Cells | MEDIAN |
| 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 | Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria. | % T-Cells | MEDIAN |
| SECONDARY | Number of Participants With Occurrence of Vaccine-induced IgG Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of Vaccine-induced IgG3 Binding Antibodies to HIV Proteins at Month 6.5 | Measured at Month 6.5 | Immunogenicity cohort. Overall Number of Participants Analyzed represents participants in the immunogenicity cohort who have samples collected at Month 6.5 and who were HIV-uninfected. Number Analyzed represents those participants with available data after filtering for assay-specific quality control criteria. | Participants | COUNT_OF_PARTICIPANTS |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT02968849/outcomes