HIV InfectionsPhase 1NCT00000837
A Study of the Safety and Effectiveness of a Chickenpox Vaccine in HIV-Infected Children
A Phase 1 study testing Varicella Virus Vaccine (Live) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 25 sites in United States.
Trial summary
The purpose of this study is to see if it is safe to give Varivax to HIV-positive children and whether it protects children from infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster). Read more about this study
- Who is it for?
- Ages 12 months to 8 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Varicella Virus Vaccine (Live)
- Type of treatment
- Vaccines
- How many people
- 127 participants
- Where
- 25 sitesUnited States
- Study dates
- Start not givento Nov 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children may be eligible for this study if they:
- Are HIV-positive with no symptoms or moderate symptoms.
- Are between 1 and 8 years old (consent of parent or guardian required).
- Have had a CD4 cell count greater than 200 for the past 3 months. If a child had a lower CD4 count before this time, then he/she must have been on stable anti-HIV therapy for the past 3 months.
Who cannot join
- Children will not be eligible for this study if they:
- Have had an infection or a fever of 101 F or higher in the past 3 days.
- Have had chickenpox or shingles. (This study has been changed. Children who had VZV infections were eligible originally.)
- Have been exposed to chickenpox or shingles in the past 4 weeks.
- Live with someone who is HIV-positive or who has a lowered immune system.
- Have certain serious diseases including tuberculosis or a disease of the immune system (other than HIV infection).
- Are allergic to any part of the chickenpox vaccine, including neomycin.
- Have recently had certain treatments or might be taking certain treatments during the study such as aspirin, VZIG, IVIG, other vaccines, steroids, anti-herpes medications, blood products, or drugs that might interfere with the immune system.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, 802181088
The Children's Hosp. (Univ. of Colorado, Denver) P7001 CRS
Aurora, Colorado
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 212874933
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 29425
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 021155724
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, 02118
Chicago Children's CRS
Chicago, Illinois, 606143394
South Florida CDTC Ft Lauderdale NICHD CRS
Fort Lauderdale, Florida, 33311
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801
Usc La Nichd Crs
Los Angeles, California, 900331079
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, 900951752
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06504
Nyu Ny Nichd Crs
New York, New York, 10016
Metropolitan Hosp. Ctr.
New York, New York, 10029
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York
NJ Med. School CRS
Newark, New Jersey, 07103
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 946091809
Children's Hosp. of Orange County
Orange, California
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 191044318
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, 146420001
UCSD Mother-Child-Adolescent Program CRS
San Diego, California, 920930672
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, 01199
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 117948111
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, 90509
About this study
Official title: Phase I/II Study of the Safety and Immunogenicity of Live-Attenuated Varicella Vaccine (Varivax) in HIV-Infected Children
The purpose of this study is to see if it is safe to give Varivax to HIV-positive children and whether it protects children from infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).
VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine that has been approved for use in healthy children. More research is needed to find out how this vaccine will affect HIV-infected children.
Read the detailed description
Primary varicella infection, or chickenpox, can be devastating to HIV-infected children because complications occur at higher rates in immunocompromised hosts. Current passive prophylaxis measures with varicella-zoster immune globulin are suboptimal because administration must be repeated for each exposure during the child's lifetime and timely notification of exposure is not always possible. Since Varivax has been licensed for routine vaccination of healthy individuals, it must be determined whether this vaccine can be safely administered to HIV-infected children.
Thirty-six children who are varicella zoster virus (VZV)-naive (treatment group) receive Varivax at Weeks 0 and 12, with a possible boost at Week 52 if the patient is still seronegative for VZV and cytomegalovirus infection. Twenty children who have a history of wild-type varicella exposure within the past year (control group) receive no study treatment. All patients are either asymptomatic or mildly symptomatic for HIV infection. Patients make 12-14 visits to the clinic. [AS PER AMENDMENT 9/9/99: This study has been reorganized into two cohorts (asymptomatic and symptomatic). In the asymptomatic cohort, accrual has been completed with 40 patients in Treatment Group I and 19 in the control group. This phase of the study demonstrated that Varivax was well tolerated in 48 HIV-infected children with asymptomatic disease. The symptomatic cohort includes Treatment Groups II and III, each with 30 patients. The first 10 patients from Group II are monitored for 42 days following the first dose of vaccine before the remaining 20 are accrued. Once the first 10 patients in Group II have been evaluated with acceptable toxicity and immunologic profiles, the remaining 20 Group II and the first 10 Group III patients are enrolled. The first 10 Group III patients are also followed for acceptable toxicity and immunologic response before accrual of the remaining 20 Group III patients.]
- Conditions
- HIV Infections
- Being tested
- Varicella Virus Vaccine (Live)
- Keywords
- Herpesvirus 3, Human, Viral Vaccines, AIDS-Related Complex, Vaccines, Attenuated, Chickenpox, Chickenpox Vaccine
- Medical subject headings
- HIV Infections, Chickenpox, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varicella Virus Vaccine (Live)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Enrolment
- 127 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Myron J Levin, Study chairAnne A Gershon, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000837
- Sponsor's protocol ID
- PACTG 265
- Other IDs
- 10613, ACTG 265
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Publications
Levin MJ, Gershon AA, Weinberg A, Blanchard S, Nowak B, Palumbo P, Chan CY; AIDS Clinical Trials Group 265 Team. Immunization of HIV-infected children with varicella vaccine. J Pediatr. 2001 Aug;139(2):305-10. doi: 10.1067/mpd.2001.115972.
PubMed 11487761
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Safety and Immunogenicity of Live-Attenuated Varicella Vaccine (Varivax) in HIV-Infected Children
- ClinicalTrials.gov ID
- NCT00000837
- Acronym / sponsor ID
- PACTG 265
- Conditions
- HIV Infections
- Keywords
- Herpesvirus 3, Human, Viral Vaccines, AIDS-Related Complex, Vaccines, Attenuated, Chickenpox, Chickenpox Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study completion
- Nov 2005 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if it is safe to give Varivax to HIV-positive children and whether it protects children from infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).
VZV can cause many serious complications in HIV-infected children. Varivax is a VZV vaccine that has been approved for use in healthy children. More research is needed to find out how this vaccine will affect HIV-infected children.
Detailed description
Primary varicella infection, or chickenpox, can be devastating to HIV-infected children because complications occur at higher rates in immunocompromised hosts. Current passive prophylaxis measures with varicella-zoster immune globulin are suboptimal because administration must be repeated for each exposure during the child's lifetime and timely notification of exposure is not always possible. Since Varivax has been licensed for routine vaccination of healthy individuals, it must be determined whether this vaccine can be safely administered to HIV-infected children.
Thirty-six children who are varicella zoster virus (VZV)-naive (treatment group) receive Varivax at Weeks 0 and 12, with a possible boost at Week 52 if the patient is still seronegative for VZV and cytomegalovirus infection. Twenty children who have a history of wild-type varicella exposure within the past year (control group) receive no study treatment. All patients are either asymptomatic or mildly symptomatic for HIV infection. Patients make 12-14 visits to the clinic. [AS PER AMENDMENT 9/9/99: This study has been reorganized into two cohorts (asymptomatic and symptomatic). In the asymptomatic cohort, accrual has been completed with 40 patients in Treatment Group I and 19 in the control group. This phase of the study demonstrated that Varivax was well tolerated in 48 HIV-infected children with asymptomatic disease. The symptomatic cohort includes Treatment Groups II and III, each with 30 patients. The first 10 patients from Group II are monitored for 42 days following the first dose of vaccine before the remaining 20 are accrued. Once the first 10 patients in Group II have been evaluated with acceptable toxicity and immunologic profiles, the remaining 20 Group II and the first 10 Group III patients are enrolled. The first 10 Group III patients are also followed for acceptable toxicity and immunologic response before accrual of the remaining 20 Group III patients.]
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 12 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Are HIV-positive with no symptoms or moderate symptoms.
- Are between 1 and 8 years old (consent of parent or guardian required).
- Have had a CD4 cell count greater than 200 for the past 3 months. If a child had a lower CD4 count before this time, then he/she must have been on stable anti-HIV therapy for the past 3 months.
Key exclusion criteria (8 listed)
- Have had an infection or a fever of 101 F or higher in the past 3 days.
- Have had chickenpox or shingles. (This study has been changed. Children who had VZV infections were eligible originally.)
- Have been exposed to chickenpox or shingles in the past 4 weeks.
- Live with someone who is HIV-positive or who has a lowered immune system.
- Have certain serious diseases including tuberculosis or a disease of the immune system (other than HIV infection).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varicella Virus Vaccine (Live) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Background: PubMed 11487761Levin MJ, Gershon AA, Weinberg A, Blanchard S, Nowak B, Palumbo P, Chan CY; AIDS Clinical Trials Group 265 Team. Immunization of HIV-infected children with varicella vaccine. J Pediatr. 2001 Aug;139(2):305-10. doi: 10.1067/mpd.2001.115972.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myron J Levin study chair
Anne A Gershon study chair
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Varicella Virus Vaccine (Live) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000837, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.