Pakistan Short Interval mOPV1 Compared With Standard Interval mOPV1 and bOPV 1,3

NCT01586572 | Completed

• 1 other identifier: 1891-Ped-ERC-11
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

Globally, polio cases have decreased by over 99% since 1988. However, wild poliovirus cases continue in Pakistan. Conflict and lack of access to children due to on-going insecurity in tribal areas present special challenges in interrupting transmission rapidly. There exists limited knowledge on the effect of shorter intervals of mOPV vaccination on immunogenicity levels in young children. The aim of this study is to demonstrate the non-inferiority of shorter intervals (7 and 14 days) between doses of mOPV1 vaccine compared to the customary interval (30 days). A 4th arm will receive bivalent (bOPV) vaccine at standard intervals beginning at 6 weeks of age.

Conditions

Polio

Keywords

Polio virus type 1,2,3; Poliovaccine-Oral; Poliovaccine; Trivalent Oral Polio vaccine; Monovalent oral polio vaccine; Bivalent Oral polio vaccine

Outcome Measures

Primary Outcomes (1)

• Seroconversion with antibodies to poliovirus type 1 following a two-dose schedule of mOPV1 given at intervals of 7 and 14 days compared to mOPV1 and bOPV1&3 given at the standard interval of 30 days.

  Humoral immunity: Sera collected at birth (cord blood or peripheral blood), at 42 days, at 79 days, at 86 days, or at 102 days (depending on study arm) will be examined for the presence (detectable) or absence of neutralizing antibodies to all three poliovirus serotypes. A reciprocal titer of \>8 is considered to indicate the presence of neutralizing antibodies. For participants with detectable antibodies, seroconversion is defined as a 4-fold increase over the expected decline of maternally-derived antibodies (half-life assumed to be 28 days).

  Participants will be followed till 102 days after birth

Secondary Outcomes (1)

• Seroconversion following the birth dose of tOPV.

  At birth

Study Arms (4)

mOPV1- Arm A

EXPERIMENTAL

Arm A will be administered a second dose of mOPV1 seven days after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at day 79.

Drug: mOPV1

mOPV1- Arm B

EXPERIMENTAL

Arm B will be administered a second dose of mOPV1 fourteen days after after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at 86 days.

Drug: mOPV1

mOPV1-Arm C

EXPERIMENTAL

Arm C will receive the second dose of mOPV1 thirty days after the 42 day mOPV1 index dose.Second dose of tOPV2 will be given at 102 days.

Drug: mOPV1

Arm D- bOPV1,3

EXPERIMENTAL

Arm D will be administered a second dose of bOPV1,3 thirty days after the 42 day bOPV1,3 index dose.Second dose of tOPV2 will be given at day 102.

Drug: bOPV 1,3

Interventions

mOPV1 DRUG

Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.

Also known as: Monovalent type 1 oral poliovirus vaccine

mOPV1- Arm A; mOPV1- Arm B; mOPV1-Arm C

bOPV 1,3 DRUG

The bivalent vaccine containing at least 106 CCID50 of Sabin poliovirus type 1 and 105•8 CCID50 of Sabin poliovirus type 3.

Also known as: Bivalent Oral Polio Vaccine

Arm D- bOPV1,3

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants \> 2.5 kg birth weight
• Immediate cry
• No neonatal IMCI danger signs
• Not planning to travel away during entire the study period (birth-102 days)

You may not qualify if:

• High-risk newborns will be excluded, as well as newborns requiring hospitalization
• Birth weight below 2.5 kg
• Cry \>2 minutes
• With any neonatal IMNCI danger signs
• Residence \>30 km from study site
• Family is planning to be absent during the birth - 102 day study period.
• A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.

Sponsors & Collaborators

• Aga Khan University: lead
• World Health Organization: collaborator

Study Sites (2)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Aga Khan University

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Mir F, Quadri F, Mach O, Ahmed I, Bhatti Z, Khan A, Rehman NU, Durry E, Salama M, Oberste SM, Weldon WC, Sutter RW, Zaidi AK. Monovalent type-1 oral poliovirus vaccine given at short intervals in Pakistan: a randomised controlled, four-arm, open-label, non-inferiority trial. Lancet Infect Dis. 2015 Aug;15(8):889-97. doi: 10.1016/S1473-3099(15)00093-6. Epub 2015 Jun 17.

  PMID: 26093979 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Anita KM Zaidi, MD; MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Fatima FM Mir, MBBS

  Aga Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairperson, Pediatrics and Child Health

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 27, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

PA (2)