Completed

Phase 2
Age: 6Months - 7Months
All Genders
Healthy Volunteers
ID00000815

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28

270

Participants Needed

46

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Months - 7Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

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.
  • 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.

Exclusion Criteria

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:

  • 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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 46 locations

1

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

Birmingham, Alabama, United States, 35233

Status Unknown

2

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

Long Beach, California, United States, 90801

Status Unknown

3

Usc La Nichd Crs

Los Angeles, California, United States, 90033

Status Unknown

4

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

Los Angeles, California, United States

Status Unknown

5

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

Oakland, California, United States, 94609

Status Unknown

6

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, United States

Status Unknown

7

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

Torrance, California, United States

Status Unknown

8

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, United States

Status Unknown

9

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

New Haven, Connecticut, United States, 06504

Status Unknown

10

Children's National Med. Ctr., ACTU

Washington D.C., District of Columbia, United States, 20010

Status Unknown

11

Howard Univ. Washington DC NICHD CRS

Washington D.C., District of Columbia, United States, 20060

Status Unknown

12

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, United States

Status Unknown

13

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

Atlanta, Georgia, United States, 30306

Status Unknown

14

Cook County Hosp.

Chicago, Illinois, United States, 60612

Status Unknown

15

Chicago Children's CRS

Chicago, Illinois, United States, 60614

Status Unknown

16

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

Chicago, Illinois, United States

Status Unknown

17

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

Chicago, Illinois, United States

Status Unknown

18

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, United States

Status Unknown

19

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

Baltimore, Maryland, United States

Status Unknown

20

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

Baltimore, Maryland, United States

Status Unknown

21

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

Boston, Massachusetts, United States

Status Unknown

22

Children's Hospital of Michigan NICHD CRS

Detroit, Michigan, United States, 48201

Status Unknown

23

UMDNJ - Robert Wood Johnson

New Brunswick, New Jersey, United States

Status Unknown

24

NJ Med. School CRS

Newark, New Jersey, United States

Status Unknown

25

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

Paterson, New Jersey, United States, 07503

Status Unknown

26

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

Albany, New York, United States, 12208

Status Unknown

27

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

Great Neck, New York, United States, 11021

Status Unknown

28

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

New Hyde Park, New York, United States, 11040

Status Unknown

29

NYU Med. Ctr., Dept. of Medicine

New York, New York, United States, 10016

Status Unknown

30

Metropolitan Hosp. Ctr.

New York, New York, United States, 10029

Status Unknown

31

Metropolitan Hosp. NICHD CRS

New York, New York, United States, 10029

Status Unknown

32

Columbia IMPAACT CRS

New York, New York, United States, 10032

Status Unknown

33

Incarnation Children's Ctr.

New York, New York, United States, 10032

Status Unknown

34

Harlem Hosp. Ctr. NY NICHD CRS

New York, New York, United States, 10037

Status Unknown

35

Strong Memorial Hospital Rochester NY NICHD CRS

Rochester, New York, United States

Status Unknown

36

SUNY Stony Brook NICHD CRS

Stony Brook, New York, United States

Status Unknown

37

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

Syracuse, New York, United States, 13210

Status Unknown

38

DUMC Ped. CRS

Durham, North Carolina, United States, 27710

Status Unknown

39

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, United States

Status Unknown

40

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

Charleston, South Carolina, United States

Status Unknown

41

Texas Children's Hosp. CRS

Houston, Texas, United States

Status Unknown

42

Childrens Hosp. of the Kings Daughters

Norfolk, Virginia, United States, 23507

Status Unknown

43

UW School of Medicine - CHRMC

Seattle, Washington, United States

Status Unknown

44

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

Bayamón, Puerto Rico

Status Unknown

45

San Juan City Hosp. PR NICHD CRS

San Juan, Puerto Rico

Status Unknown

46

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

San Juan, Puerto Rico

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Sulachni Chandwani, Judy Beeler, Hong Li...

https://pubmed.ncbi.nlm.nih.gov/21666159