At a glance
ClinicalIndex Comparison Record- ✓Negative for HIV infection at screening
- ✓Healthy based on physical exam, medical history, ECG, and vital signs
- ✓Assessed by clinic staff as being at low risk for HIV infection
- ✓Willing and able to adhere to protocol prohibitions and study procedures
- ✕Chronic hepatitis B (hepatitis B surface antigen positive)
- ✕Active hepatitis C (HCV RNA PCR positive)
- ✕Active syphilis infection (documented by serology)
- ✕Chlamydia, gonorrhea, or trichomonas infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess the Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens; Priming With Trivalent Ad26.Mos.HIV and Boosting With Trivalent Ad26.Mos.HIV And Clade C Gp140 Plus Adjuvant or Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Clade C Gp140 Plus Adjuvant
In Brief
A Phase 2 clinical trial evaluating Ad26.Mos.HIV, Ad26.Mos4.HIV, and 2 other interventions for Healthy. Completed, enrolled 201 participants across 10 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.
Study Details
Timeline
Interventions
Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5\*10\^10 viral particle per 0.5mL injection administered intramuscularly.
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.