Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073216
Status:
COMPLETED
Last Update Posted:
2021-10-14
First Post:
2003-11-18
Brief Title:
Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Clade B Gag DNAPLG and Env DNAPLG Microparticles Vaccine and a Clade B Recombinant Oligomeric gp140MF59 Adjuvant Vaccine in Healthy HIV-1 Uninfected Adult Participants
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To prevent HIV infection a vaccine that produces strong HIV-specific humoral B-cell and cellular T-cell immune system responses is desirable The purpose of this study is to test the safety of and immune response to a novel combination HIV vaccine in HIV uninfected adults This study will also test the safety of and immune response to a protein vaccine given alone
Detailed Description:
The development of a vaccine eliciting HIV-specific humoral and cellular immune responses is desirable for the prevention of HIV infection This study will investigate a combination vaccine regimen consisting of priming with DNA followed by boosting with a recombinant envelope glycoprotein adjuvanted in MF59
All participants will be followed for 15 months Participants enrolled in Groups 1 2 3 and 4 will receive either the vaccine or placebo Study visits will be completed at initial entry five visits every 14 days for the first 25 months and visits at Months 4 45 6 65 9 95 12 and 15 All participants will undergo physical exams urine collection and blood tests to assess safety HIV infection and immune responses to injections Risk reductionpregnancy prevention counseling will be given at every study visit Participants will also be asked to complete questionnaires about outside testing and beliefs at certain visits
There are two parts to this study In Part A participants will be sequentially assigned to one of three groups Each group will receive injections of different amounts of either DNA vaccine or placebo at entry Month 1 and Month 2 This is followed by identical injections of glycoproteinadjuvant or placebo at Months 6 and 9 Group 1 will receive 250 mcg each of the gag and env DNA plasmid with microparticle vaccine Group 2 will receive 500 mcg of each vaccine Group 3 will receive 1000 mcg of each vaccine Participants will be enrolled sequentially from low to high dose beginning with Group 1
In Part B Group 4 will begin the second part of the study simultaneously after safety review of all participants in Part A Group 4 participants will receive identical injections of either DNA vaccine or placebo at entry and at Months 1 2 6 and 9
Group 5 will begin enrollment after enrollment is completed for Groups 1 2 3 and 4 Group 5 participants will receive identical injections of either glycoproteinadjuvant or placebo at study entry and at Months 3 and 9 There will be 11 study visits for Group 5 participants they will occur at screening study entry and Months 05 2 3 35 6 9 95 12 and 15 A physical exam and risk reductionpregnancy prevention counseling will occur at all visits participants will be asked at every visit about any adverse events they may have experienced Blood and urine collection will occur at selected visits Participants will be also asked to complete questionnaires about outside testing and beliefs at certain visits
All participants will be followed for 15 months Participants enrolled in Groups 1 2 3 and 4 will receive either the vaccine or placebo Study visits will be completed at initial entry five visits every 14 days for the first 25 months and visits at Months 4 45 6 65 9 95 12 and 15 All participants will undergo physical exams urine collection and blood tests to assess safety HIV infection and immune responses to injections Risk reductionpregnancy prevention counseling will be given at every study visit Participants will also be asked to complete questionnaires about outside testing and beliefs at certain visits
There are two parts to this study In Part A participants will be sequentially assigned to one of three groups Each group will receive injections of different amounts of either DNA vaccine or placebo at entry Month 1 and Month 2 This is followed by identical injections of glycoproteinadjuvant or placebo at Months 6 and 9 Group 1 will receive 250 mcg each of the gag and env DNA plasmid with microparticle vaccine Group 2 will receive 500 mcg of each vaccine Group 3 will receive 1000 mcg of each vaccine Participants will be enrolled sequentially from low to high dose beginning with Group 1
In Part B Group 4 will begin the second part of the study simultaneously after safety review of all participants in Part A Group 4 participants will receive identical injections of either DNA vaccine or placebo at entry and at Months 1 2 6 and 9
Group 5 will begin enrollment after enrollment is completed for Groups 1 2 3 and 4 Group 5 participants will receive identical injections of either glycoproteinadjuvant or placebo at study entry and at Months 3 and 9 There will be 11 study visits for Group 5 participants they will occur at screening study entry and Months 05 2 3 35 6 9 95 12 and 15 A physical exam and risk reductionpregnancy prevention counseling will occur at all visits participants will be asked at every visit about any adverse events they may have experienced Blood and urine collection will occur at selected visits Participants will be also asked to complete questionnaires about outside testing and beliefs at certain visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10054 | REGISTRY | DAIDS ES Registry Number | None |