Randomized Controlled Trial of Measles Vaccination Schedule

Summary

Measles is a preventable infectious viral disease. Since 1985, India has been administering a single dose of measles vaccine to all infants at 9 months of age. This age was chosen to balance the disappearance of maternal (transplacental) antibodies with the increasing risk of developing measles. Thus infants are expected to get protection against measles by acquired maternal measles antibodies derived trans-placentally from the mother for the first 9 months of life. Thereafter vaccine-induced antibodies are expected to protect infants. Seroconversion after measles vaccination does not take place as long as maternal measles antibodies persist in the infant. However, it is widely recognized that a substantial proportion of measles infection (10 to 15%) can occur among infants before the age of measles vaccination. Further, two small cohort studies done in our institution confirm that the majority of infants lose maternal antibodies by six months of age, making them susceptible to measles.This argues strongly for anticipating measles vaccination to an earlier age. However, such early vaccination has the risk that residual maternal antibodies (even if insufficient to protect infants) can neutralize the antigen in the vaccine, rendering vaccination ineffective. Therefore, a careful balance has to be chosen so that low levels of circulating maternal antibodies do not interfere with infants' response to vaccination. However, there is no prospective study in Indian infants to determine the seroconversion and sero-protection rate of earlier vaccination.

This study has following aims and objectives:

1. To study the level of measles specific immunoglobulin G (IgG) antibodies in a cohort of term infants followed from birth to 9 months of age; and the pattern of antibody decline in them.
2. To compare the levels of antibodies in infants at these time points and correlate the levels with the antibody level in the respective mothers at the time of delivery.
3. To compare the efficacy and safety of three different measles vaccination schedules in a cohort of term infants viz (i) vaccination at 9 months of age (current practice), (ii) vaccination at 7.5 months and 9 months of age, and (iii) vaccination at 6 months and 9 months of age.

Conditions

• MEASLES DISEASE

Interventions

BIOLOGICAL

Measles vaccine

Live attenuated measles vaccine of brands currently being used in National Immunization Schedule of India.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  lead OTHER

Principal Investigators

• LAXMI MAKAM · Post Graduate Institute of Medical Education and Research, Chandigarh

• JOSEPH L MATHEW · Post Graduate Institute of Medical Education and Research, Chandigarh

• SOURABH DUTTA · Post Graduate Institute of Medical Education and Research, Chandigarh

• VANITA SURI · Post Graduate Institute of Medical Education and Research, Chandigarh

• R K RATHO · Post Graduate Institute of Medical Education and Research, Chandigarh

• BHAVNEET BHARTI · Post Graduate Institute of Medical Education and Research, Chandigarh

• MINI P SINGH · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-03-14

Primary Completion

2018-05-31

Completion

2018-05-31

Countries

• India

Study Locations