Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000774
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
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 Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
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:
PRIMARY To determine the safety of envelope recombinant proteins rgp120HIV-1MN Genentech and rgp120HIV-1SF2 ChironBiocine in infants who are of indeterminate HIV status born to HIV-infected women To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in all immunized infants
SECONDARY To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women
Only 30-50 percent of HIV-infected infants have detectable virus at birth Successful early sensitization to HIV envelope epitopes may help prevent infection or alternatively may enhance HIV-specific immune function to alter HIV replication and disease progression
SECONDARY To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women
Only 30-50 percent of HIV-infected infants have detectable virus at birth Successful early sensitization to HIV envelope epitopes may help prevent infection or alternatively may enhance HIV-specific immune function to alter HIV replication and disease progression
Detailed Description:
Only 30-50 percent of HIV-infected infants have detectable virus at birth Successful early sensitization to HIV envelope epitopes may help prevent infection or alternatively may enhance HIV-specific immune function to alter HIV replication and disease progression
Newborns are randomized to one of three different doses of either rgp120HIV-1MN or rgp120HIV-1SF2 or their matching placebos At each dose level 12 patients receive vaccine and three patients receive placebo Immunizations are performed at 0 4 12 and 20 weeks and patients are followed until 2 years of age Three of four patients treated at a given dose level must have received two immunizations without evidence of grade 3 or 4 clinical or laboratory toxicity before dose escalation occurs Twelve additional patients are treated with the optimal dose of each vaccine at weeks 0 2 8 and 20 An accelerated schedule PER AMENDMENT 32096 Changed from - 0 4 8 and 20 accompanied by three additional placebo patients per vaccine PER AMENDMENT 32096 The optimal dose of rgp120HIV-1MN is 100 mcg and will be given to the 12 patients and the placebo will be given to 3 The optimal dose of rgp120HIV-1SF2 is 5 mcg and will be given to the 12 patients and the placebo will be given to 3
PER 2395 AMENDMENT After the initial patients are enrolled 18 additional newborns will be randomized to one of the three dose levels of rgp120HIV-1MN with no placebos PER AMENDMENT 6595 Another group of 18 newborns will be randomized to one of three treatments representing 3 different doses of the ChironBiocine vaccine with no placebos
Newborns are randomized to one of three different doses of either rgp120HIV-1MN or rgp120HIV-1SF2 or their matching placebos At each dose level 12 patients receive vaccine and three patients receive placebo Immunizations are performed at 0 4 12 and 20 weeks and patients are followed until 2 years of age Three of four patients treated at a given dose level must have received two immunizations without evidence of grade 3 or 4 clinical or laboratory toxicity before dose escalation occurs Twelve additional patients are treated with the optimal dose of each vaccine at weeks 0 2 8 and 20 An accelerated schedule PER AMENDMENT 32096 Changed from - 0 4 8 and 20 accompanied by three additional placebo patients per vaccine PER AMENDMENT 32096 The optimal dose of rgp120HIV-1MN is 100 mcg and will be given to the 12 patients and the placebo will be given to 3 The optimal dose of rgp120HIV-1SF2 is 5 mcg and will be given to the 12 patients and the placebo will be given to 3
PER 2395 AMENDMENT After the initial patients are enrolled 18 additional newborns will be randomized to one of the three dose levels of rgp120HIV-1MN with no placebos PER AMENDMENT 6595 Another group of 18 newborns will be randomized to one of three treatments representing 3 different doses of the ChironBiocine vaccine with no placebos
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 |
|---|---|---|---|
| 11207 | REGISTRY | DAIDS ES Registry Number | None |