Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| World Health Organization | OTHER |
| Centers for Disease Control and Prevention, China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
This is an open label and off label, phase IV, randomized clinical trial that will compare the immune response among infants that receive either two full doses of Sabin IPV intramuscularly or two fractional (1/5) dose of Sabin IPV intradermally at 14 weeks and 9 months of age from two different manufacturers.
After OPV cessation, which is expected within a year of polio eradication certification, IPV will be the only polio vaccine used in essential immunization programs. SAGE has recommended a two-dose intramuscular IPV or intradermal fractional IPV (fIPV) schedule after OPV cessation. While it is expected that there shall be sufficient IPV available - in large part because of several manufacturers establishing production of IPV using Sabin strains (sIPV) - it is dependent on these manufacturers being able to meet promised product development and manufacturing timeline and meet WHO prequalification. It is likely that countries that have introduced intradermal fIPV pre-eradication will continue to use intradermal fIPV post-eradication. Therefore, it is important to generate evidence on immunogenicity of intradermal fractional sIPV in addition to intramuscular sIPV for the schedule recommended by SAGE.
This clinical trial assesses and compares the immunogenicity of full and fractional (1/5) dose Sabin IPV given at 14 weeks and 9 months of age from two different manufacturers. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of four arms:
A. IMBCAMS full dose sIPV at 14 weeks and 9 months B. IMBCAMS fractional dose sIPV at 14 weeks and 9 months C. BIBP full dose sIPV at 14 weeks and 9 months D. BIBP fractional dose sIPV at 14 weeks and 9 months
Participants will be followed until 10 months of age through clinic visits. Blood samples will be collected for measuring immune response.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMBCAMS Sabin IPV full dose at 14 weeks and 9 months | Active Comparator | Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS). |
|
| IMBCAMS Sabin IPV fractional dose at 14 weeks and 9 months | Active Comparator | Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Institute of Medical Biology Chinese Academy of Medical Sciences, Kunming (IMBCAMS). |
|
| BIBP Sabin IPV full dose at 14 weeks and 9 months | Active Comparator | Participants will receive two full doses of Sabin IPV intramuscularly at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP). |
|
| BIBP Sabin IPV fractional dose at 14 weeks and 9 months | Active Comparator | Participants will receive two fractional (1/5) doses of Sabin IPV intradermally at 14 weeks and 9 months produced by Beijing Bio Institute Biological Products (BIBP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS | Biological | The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intramuscularly by needle and syringe. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine response | Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days. | Measured 4 weeks after administration of study vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Reciprocal antibody titers | Variable of the observed reciprocal antibody titer results. | Measured 4 weeks after administration of study Vaccine |
| Priming | Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 14 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Khalequ Zaman, PhD | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icddr,B Study Clinics | Dhaka | Bangladesh |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fractional (1/5) Dose Sabin Inactivated Poliovirus Vaccine produced by IMBCAMS | Biological | The Sabin antigen content is 30, 32 and 45 D-antigen units (DU) for types 1, 2 and 3, respectively and will be delivered intradermally by needle and syringe. |
|
| Full dose Sabin Inactivated Poliovirus Vaccine produced by BIBP | Biological | The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intramuscularly by needle and syringe |
|
| Fractional (1/5) dose Sabin Inactivated Poliovirus Vaccine produced by BIBP | Biological | The Sabin antigen content is 15 DU, 45 DU, 45 DU for types 1, 2, and 3, respectively and will be delivered intradermally by needle and syringe |
|
| Measured 7 days after challenge dose (e.g. 9 months + 7 days) |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided