Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339040
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2006-06-19
Brief Title:
Safety of and Immune Response to a Novel Human Papillomavirus Vaccine in HIV Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase II Safety and Immunogenicity Study of Quadrivalent Human Papillomavirus Types 6 11 16 18 L1 Virus-Like Particle VLP Vaccine in HIV Infected Children 7 to 12 Years of Age
Status:
COMPLETED
Status Verified Date:
2019-01
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:
The purpose of this study is to determine the safety of and immune response to a new human papillomavirus HPV vaccine in HIV Human immunodeficiency virus infected children between the ages of 7 and 12 years
Detailed Description:
Genital HPV infection is the most common sexually transmitted infection in the world and may lead to genital warts anogenital dysplasias and invasive cancers HIV infected people and others with compromised immunity are at greater risk for HPV-related complications In particular researchers are concerned about the risk of HPV infection to women who may be infected by their male partners especially if these partners engage in anal intercourse HIV infected women tend to have multiple types of HPV associated with a greater risk of HPV-related disease are less likely to clear HPV-related conditions and are more likely to progress to HPV-related disease The quadrivalent HPV types 6 11 16 18 L1 virus-like particle VLP vaccine to be tested in this study was safe and generally well tolerated in previous studies conducted in healthy and HPV-exposed adolescents young adults and older women However it is still unclear if the vaccine will be safe and will elicit a similar immune response in younger children The purpose of this study is to evaluate the safety and immunogenicity of the novel quadrivalent HPV Types 6 11 16 18 L1 VLP vaccine in HIV infected children 7 to 12 years of age
This study had two stages and lasted at least 108 weeks In Stage I participants were stratified by CD4 percentage CD4 nadir and CD4 at study screening Stratum A CD4 Nadir 15 and CD4 15 at screening Stratum B CD4 Nadir 15 and 25 and CD4 15 at screening Stratum C CD4 Nadir 25 and CD4 25 at screening Within each stratification group they were randomly assigned to one of two arms During Stage I Arm A QHPVQuadrivalent human papillomavirus vaccine participants received 3 doses of vaccine while Arm B PlaceboQHPV participants received 3 doses of placebo Participants did not know whether they were receiving vaccine or placebo Participants received their assigned intervention at study entry and Weeks 8 and 24 At Week 96 Stage II began and all study participants were told if they received vaccine or placebo in Stage I Arm A participants received an additional dose of vaccine at Week 96 Arm B participants received doses of vaccine at Weeks 96 104 and 120 Over the course of the study there were at least 12 study visits A physical exam and blood collection occurred at most visits medical history occurred at selected visits
After each vaccination participants were observed for at least 30 minutes to monitor for any allergic reactions possibly resulting from the vaccination For 15 days following vaccination parents or guardians were asked to complete a report card with details of each childs signs and symptoms Three days after each vaccination parents or guardians of study participants were contacted by telephone and asked about any adverse events that a child may have experienced
This study had two stages and lasted at least 108 weeks In Stage I participants were stratified by CD4 percentage CD4 nadir and CD4 at study screening Stratum A CD4 Nadir 15 and CD4 15 at screening Stratum B CD4 Nadir 15 and 25 and CD4 15 at screening Stratum C CD4 Nadir 25 and CD4 25 at screening Within each stratification group they were randomly assigned to one of two arms During Stage I Arm A QHPVQuadrivalent human papillomavirus vaccine participants received 3 doses of vaccine while Arm B PlaceboQHPV participants received 3 doses of placebo Participants did not know whether they were receiving vaccine or placebo Participants received their assigned intervention at study entry and Weeks 8 and 24 At Week 96 Stage II began and all study participants were told if they received vaccine or placebo in Stage I Arm A participants received an additional dose of vaccine at Week 96 Arm B participants received doses of vaccine at Weeks 96 104 and 120 Over the course of the study there were at least 12 study visits A physical exam and blood collection occurred at most visits medical history occurred at selected visits
After each vaccination participants were observed for at least 30 minutes to monitor for any allergic reactions possibly resulting from the vaccination For 15 days following vaccination parents or guardians were asked to complete a report card with details of each childs signs and symptoms Three days after each vaccination parents or guardians of study participants were contacted by telephone and asked about any adverse events that a child may have experienced
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 |
|---|---|---|---|
| 10163 | REGISTRY | None | None |
| PACTG P1047 | Registry Identifier | DAIDS ES Registry Number | None |