CompletedPhase 1

Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adults

United States117 participantsStarted 2017-08-22

Plain-language summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: General and Demographic Criteria: * Age of 18 through 50 years * Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this study, completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent before the last required protocol clinic visit * Willing to be contacted by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling. * Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. Laboratory Inclusion Values: Hemogram/Complete Blood Count (CBC): * Hemoglobin greater than or equal to 11.5 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male * White blood cell count equal to 3,300 to 12,000 cells…

What they're measuring

Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime

Timeframe: Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12

Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime

Timeframe: Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12

Part A: Number of Participants With Early Study Termination Associated With an Adverse Event (AE) or Reactogenicity During the Vaccine Regime

Timeframe: Measured through Month 24

Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity

Timeframe: Measured through the Month 12 boost

Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15

Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15

Trial details

NCT IDNCT03220724

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2023-03-21

Results submitted2021-07-14

View on ClinicalTrials.gov More HIV Infections trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regime

Timeframe: Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12

Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Vaccine Regime

Timeframe: Measured through Month Measured through 7 days after the vaccination at Month 0, 2, 4, 8, 12

Part A: Number of Participants With Early Study Termination Associated With an Adverse Event (AE) or Reactogenicity During the Vaccine Regime

Timeframe: Measured through Month 24

Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity

Timeframe: Measured through the Month 12 boost

Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) in U/L

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15

Part A: Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL

Timeframe: Measured during screening, and 2 weeks after each vaccination at Month 0, 2, 4, 8, 12, and at Month 15