Ontogeny of Measles Immunity in Infants

Ontogeny of Vaccine-Induced Measles Immunity Child Participant-6 and 9 Months

This is an immunogenicity study evaluating the development of the immune response of healthy infants following primary vaccination with Attenuvax at 6 or 9 months of age compared with responses in 12 month-old infants receiving MMR-II. Responses of infants receiving an early two dose measles vaccine regimen with the first dose given at 6 or 9 months followed by a second dose administered at 12 months will also be compared to infants given a single dose at 12 months of age (Table 2). The current approved regimen for measles vaccination is a first vaccination at 12-15 months and a subsequent vaccination at school entry.

A secondary endpoint of this study will be to assess the safety of measles vaccine administered as Attenuvax at 6 or 9 months of age and in an early two dose measles vaccine regimen with Attenuvax administered at 6 or 9 months followed by MMR-II at 12 months of age.

Study Overview

• Status: Completed
• Conditions: Measles
• Intervention / Treatment: Biological: Attenuvax (Measles Virus Live Vaccine, 0.5ml subcutaneous); Biological: MMR-II (Measles-Mumps-Rubella Virus Live Vaccine, 0.5ml subcutaneous)

Detailed Description

This is an open-label immunogenicity and safety study of live attenuated Measles Vaccine (Attenuvax) and Measles-Mumps-Rubella (MMR-II) vaccine administered to healthy children at 6 (n=70), 9 (n=70), or 12 (n=70) months of age. Attenuvax (Measles Virus Vaccine Live, Merck & Co., Inc) and MMR-II (Measles-Mumps-Rubella Virus Vaccine Live, Merck & Co., Inc) will be delivered as 0.5 mL per dose, administered subcutaneously. Both vaccines are licensed for use in infants in the United States. MMR-II is recommended as part of the childhood immunization schedule by the AAP and ACIP, and Attenuvax is recommended for use as a single component vaccine in infants 6-11 months particularly for foreign travel and in measles outbreaks79. Infants vaccinated with Attenuvax at 6 or 9 months receive MMR-II at 12 months of age as recommended for follow-up vaccination. Immunization against measles is given as a trivalent formulation with mumps and rubella and is indicated as a primary dose at 12-15 months of age with a second dose recommended routinely at time of school entry, 4-6 years of age, but can be given at any earlier age provided that the interval between the first and second doses is at least 4 weeks .

Two hundred and ten healthy children attending the Palo Alto Medical Clinic will be recruited into one of three cohorts over a five year period. (Table 1). All children in cohort 1 and 2 (6 and 9 month old infants) will receive Attenuvax as part of their participation in this study followed by MMR-II at 12 months of age as part of their routine WCC and not as a study vaccine. Infants recruited into cohort 3, (twelve month old infants) will receive one dose of MMR-II at 12 months. All infants in the study (cohort 1, 2 or 3) are receiving MMR-II at 12 months as part of their routine childhood vaccines. The vaccination schedules is summarized in Table 1. Other immunizations as required for routine WCC will be administered simultaneously. Participation will entail 2-4 visits, 2-3 blood samples, and 1-2 immunizations and will end after the 9-18 month visit, totaling 3 to 12 months time of participation for a subject depending on cohort and if participants opt for a second follow-up blood sample.

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • Palo Alto Medical Foundation/Department of Pediatrics
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study populations include infants who are 6, 9, and 12 months of age, and healthy adults older than 18 years.

Description

Inclusion Criteria:Subjects must meet all of the following criteria in order to be enrolled:

1. Healthy infants 6, 9, or 12 months (+ 3 weeks) of age
2. Free of obvious health problems as established by medical history and clinical examination before entering into the study
3. Parent/legal guardian willing and capable of signing written informed consent
4. Parent/legal guardian expected to be available for entire study
5. Parent/legal guardian can be reached by telephone

Exclusion Criteria:All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:

1. Former premature infants (<36 weeks)
2. Birth weight < 2500grams
3. Significant underlying chronic illness
4. Immunodeficiency disease or immunosuppressive therapy in the participant
5. Any other condition which in the clinical judgment of the investigator might interfere with vaccine evaluation
6. Allergy to any components of the vaccine, including anaphylaxis or anyphalaxoid reaction to neomycin or eggs
7. Administration of an investigational drug
8. Blood products within 3 months of initial enrollment
9. Current febrile respiratory illness or other active febrile infection
10. Family history of congenital/hereditary immunodeficiency, unless immune competence of subject has been determined.
11. Blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the bone marrow or lymphatic systems.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immune response to measles vaccine	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Affect of maternal antibodies on immune response to measles vaccine.	6 mo

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Hayley Altman Gans, Stanford University

Study record dates

Study Major Dates

• Study Start: July 1, 1993
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: October 14, 2005
• First Submitted That Met QC Criteria: October 14, 2005
• First Posted (Estimate): October 18, 2005

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 6, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Measles; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: SU-11142008-1344; DMID Protocol #05-0039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data is shared as requested by other investigators including raw data and summarized data
• IPD Sharing Time Frame: Is available
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No