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HIV InfectionsPhase 2NCT00000815

A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group

A Phase 2 study testing Attenuvax and M-M-R-II in people with HIV Infections and Measles, run by National Institute of Allergy and Infectious Diseases (NIAID) at 46 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare measles seroconversion rates (development of antibodies) at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules: attenuated measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine (Attenuvax) at 6 months plus M-M-R II vaccine at… Read more about this study

Who is it for?
Ages 6 to 7 monthsHealthy volunteers can take part
Conditions the study is for
HIV Infections, Measles
What is being tested?
Attenuvax and M-M-R-II
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
46 sitesin 2 countries
Study dates
Start not givento Aug 2001
Phase
Phase 2
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 6 to 7 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Patients must have:
  • Willing to have and receive results of HIV test
  • Been born to mothers with HIV infection or history of AIDS-defining condition by CDC criteria.
  • No history of opportunistic infection.
  • No known exposure to measles within 14 days prior to study entry.
  • CD4+ lymphocyte count >= 750 cells/mm3 or more than 15% at 6 months of age.
Show all 14Show fewer
  • Parent or legal guardian available to give written informed consent and be willing to comply with all study requirements.
  • Childhood immunizations (other than measles) according to current recommendations of the Immunization Practice Advisory Committee and American Academy of Pediatrics.
  • NOTE:
  • Coenrollment on other therapeutic protocols (except for ACTG 185) is permitted.
  • NOTE:
  • Patients must be located in a geographical area where measles immunization at 12 months is standard of care.
  • Recommended:
  • Childhood immunizations other than measles according to current guidelines.

Who cannot join

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Intercurrent illness and/or fever for 7 days.
  • Known sensitivity or allergy to neomycin or eggs.
  • Concurrent Medication:
  • Excluded:
Show all 13Show fewer
  • IVIG.
  • Uninterrupted or anticipated steroid therapy (>= 2 mg/kg/day) for more than 2 weeks duration.
  • Patients with the prior condition are excluded:
  • Platelet count < 50,000/mm3 at any time prior to study entry.
  • Prior Medication:
  • Excluded:
  • Any IgG preparation within the past 6 months.

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

United States43 sites

  • Children's Hospital at Albany Medical Center, Dept. of Peds.

    Albany, New York, 12208

  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases

    Atlanta, Georgia, 30306

  • Univ. of Colorado Denver NICHD CRS

    Aurora, Colorado

  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

    Baltimore, Maryland

  • Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology

    Baltimore, Maryland

  • UAB, Dept. of Ped., Div. of Infectious Diseases

    Birmingham, Alabama, 35233

  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases

    Boston, Massachusetts

  • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases

    Charleston, South Carolina

  • Cook County Hosp.

    Chicago, Illinois, 60612

  • Chicago Children's CRS

    Chicago, Illinois, 60614

  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

    Chicago, Illinois

  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.

    Chicago, Illinois

  • Children's Hospital of Michigan NICHD CRS

    Detroit, Michigan, 48201

  • DUMC Ped. CRS

    Durham, North Carolina, 27710

  • North Shore-Long Island Jewish Health System, Dept. of Peds.

    Great Neck, New York, 11021

  • Texas Children's Hosp. CRS

    Houston, Texas

  • Univ. of Florida Jacksonville NICHD CRS

    Jacksonville, Florida

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.

    Long Beach, California, 90801

  • Usc La Nichd Crs

    Los Angeles, California, 90033

  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

    Los Angeles, California

  • UMDNJ - Robert Wood Johnson

    New Brunswick, New Jersey

  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

    New Haven, Connecticut, 06504

  • Schneider Children's Hosp., Div. of Infectious Diseases

    New Hyde Park, New York, 11040

  • Tulane/LSU Maternal/Child CRS

    New Orleans, Louisiana

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York, 10016

  • Metropolitan Hosp. Ctr.

    New York, New York, 10029

  • Metropolitan Hosp. NICHD CRS

    New York, New York, 10029

  • Columbia IMPAACT CRS

    New York, New York, 10032

  • Incarnation Children's Ctr.

    New York, New York, 10032

  • Harlem Hosp. Ctr. NY NICHD CRS

    New York, New York, 10037

  • NJ Med. School CRS

    Newark, New Jersey

  • Childrens Hosp. of the Kings Daughters

    Norfolk, Virginia, 23507

  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.

    Oakland, California, 94609

  • St. Joseph's Hosp. & Med. Ctr. of New Jersey

    Paterson, New Jersey, 07503

  • The Children's Hosp. of Philadelphia IMPAACT CRS

    Philadelphia, Pennsylvania

  • Strong Memorial Hospital Rochester NY NICHD CRS

    Rochester, New York

  • UCSD Maternal, Child, and Adolescent HIV CRS

    San Diego, California

  • UW School of Medicine - CHRMC

    Seattle, Washington

  • SUNY Stony Brook NICHD CRS

    Stony Brook, New York

  • SUNY Upstate Med. Univ., Dept. of Peds.

    Syracuse, New York, 13210

  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

    Torrance, California

  • Children's National Med. Ctr., ACTU

    Washington D.C., District of Columbia, 20010

  • Howard Univ. Washington DC NICHD CRS

    Washington D.C., District of Columbia, 20060

Other trials in United States

Puerto Rico3 sites

  • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.

    Bayamón

  • San Juan City Hosp. PR NICHD CRS

    San Juan

  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

    San Juan

Other trials in Puerto Rico

About this study

To compare measles seroconversion rates (development of antibodies) at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules: attenuated measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months.

Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.

Read the detailed description

Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.

Patients, HIV infected and uninfected, are randomized to one of two attenuated measles vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are followed for 24 months after the last vaccination.

Being tested
Attenuvax, M-M-R-II
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Measles-Mumps-Rubella Vaccine, Vaccines, Attenuated, Measles Vaccine, Immunization Schedule, Measles Virus, Measles
Medical subject headings
HIV Infections, Measles, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AttenuvaxBiological

    Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age

  • M-M-R-IIBiological

    Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age

Study groups in NCT00000815
Study groupRoleWhat they receive
1ExperimentalParticipants who receive vaccination at 6 and 12 months of age
Receives: Biological: Attenuvax; Biological: M-M-R-II
2ExperimentalParticipants who receive vaccination only at 12 months of age
Receives: Biological: M-M-R-II

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age

    Measured: Throughout study

  2. Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children.

    Measured: Throughout study

  3. Comparison of seroconversion rates at 13 months of age (following single vaccination) of HIV-uninfected children with HIV-infected children following vaccination at 12 months of age

    Measured: Throughout study

Secondary outcomes (3)

  1. Comparison of measles seroconversion rates in HIV-infected children vaccinated at 6 months of age with HIV-infected children vaccinated at 12 months of age

    Measured: Throughout study

  2. Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees

    Measured: Throughout study

  3. Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionAug 2001

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000815
Sponsor's protocol ID
ACTG 225
Other IDs
11202
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
28 Oct 2021
Results posted
No

Publications

  • Chandwani S, Beeler J, Li H, Audet S, Smith B, Moye J, Nalin D, Krasinski K; PACTG 225 Study Team. Safety and immunogenicity of early measles vaccination in children born to HIV-infected mothers in the United States: results of Pediatric AIDS Clinical Trials Group (PACTG) protocol 225. J Infect Dis. 2011 Jul;204 Suppl 1(Suppl 1):S179-89. doi: 10.1093/infdis/jir089.

    PubMed 21666159

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Attenuvax and M-M-R-II in people with HIV Infections and Measles, run by National Institute of Allergy and Infectious Diseases (NIAID) at 46 sites in 2 countries.

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 14 inclusion and 13 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 28 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 46 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age (time frame: Throughout study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000815, 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 28 Oct 2021.

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