Immunogenicity nOPV2 With and Without bOPV

Centers for Disease Control and Prevention (CDC)

Status and phase: Completed; Phase 2

Conditions: Poliomyelitis

Treatments: Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2); Biological: Bivalent oral poliovirus vaccine (bOPV)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04579510

20060

Details and patient eligibility

About

This is an open-label randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.

Full description

It is expected that nOPV2 would replace mOPV2 for responding to type 2 outbreaks. Outbreak response for cVDPV2 also offers the opportunity to close immunity gaps to polioviruses types 1 and 3. Furthermore, GPEI might have to respond to two poliovirus outbreaks in the same geography. For either scenario, it would be important to get data on the immunogenicity of co-administered nOPV2 and bOPV, compared to either vaccine given alone.

This clinical trial assesses and compares the immunogenicity of nOPV2 given with or without bOPV. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of three study arms â " Arm A: nOPV2 only, Arm B: nOPV2 and bOPV, or Arm C: bOPV only. Infants will be followed-up until 18 weeks of age through clinic and household visits. Blood specimens will be collected to test for immunological response. Stool specimens will be collected from infant vaccine recipients and one sibling household contact each to assess viral recombinants and nOPV2 household transmission.

Enrollment: 795 patients

Sex: All

Ages: 42 to 48 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy infants 6 weeks of age (range: 42-48 days).
• Parents that consent for participation in the full length of the study.
• Parents that can understand and comply with planned study procedures.
• Infant has at least one sibling aged <10 years living in the same household that is eligible for participation in the study.

Exclusion criteria

• Parents and infants who are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).
• A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• A diagnosis or suspicion of bleeding disorder that would contraindicate administration of bOPV or nOPV2 or collection of blood by venipuncture.
• Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
• Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
• Evidence of a chronic medical condition identified by a study medical officer during physical exam.
• Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
• Known allergy/sensitivity or reaction to polio vaccine, or its contents.
• Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
• Infants from premature births (<37 weeks of gestation).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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795 participants in 3 patient groups

nOPV2 only

Active Comparator group

Description:

Participants in this arm will receive nOPV2 at 6, 10, and 14 weeks of age

Treatment:

Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2)

nOPV2 and bOPV

Active Comparator group

Description:

Participants in this arm will receive both nOPV2 and bOPV at 6, 10, and 14 weeks of age

Treatment:

Biological: Bivalent oral poliovirus vaccine (bOPV)

Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2)

bOPV only

Active Comparator group

Description:

Participants in this arm will receive bOPV at 6, 10, and 14 weeks of age

Treatment:

Biological: Bivalent oral poliovirus vaccine (bOPV)