Appendix A.pdf
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- Solicitation number
- FDA_20-233-1229716
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This document outlines a study to evaluate the duration of pertussis immunity in baboons. The study will involve vaccinating 48 baboons with either an acellular pertussis vaccine or whole-cell pertussis vaccine in a series of three doses administered two months apart. Twelve additional baboons that previously participated in other studies will serve as convalescent controls. Extensive blood and tissue sampling will be performed around each vaccination and periodically over four years to assess immune responses. Parameters such as transcriptomics, cytokines, B-cell and T-cell memory responses will be evaluated. The Food and Drug Administration is seeking these services to understand durability of protection from the different pertussis vaccines.
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FDA_20-233-1229716
Performance of Duration of Pertussis Immunity in Baboons Study
Appendix A
Animals will be vaccinated three times, two-months apart with either aP or wP vaccine.
Extensive sampling will be performed around the vaccinations. Following vaccinations, blood, bone marrow and BAL will be collected twice per year when animals are sedated for semi-annual TB testing. It is anticipated, the study will continue for 4 years but may be continued based on results.
Groups:
• Twelve animals vaccinated three times, two months apart starting at 5-7 months of age with acellular pertussis vaccine
• Twelve animals vaccinated three times, two months apart starting at 5-7 months of age with whole-cell pertussis vaccine
• Twelve convalescent baboons returned from studies at CBER.
• Twelve age-matched unvaccinated animals from the colony.
Procedure Schedule:
First Vaccination:
Day -30: Draw blood
2.5 mls for PaxGene (transcriptomics) 4 mls for PBMCs (transcriptomics) and plasma (antigen ELISAs and banking for proteomics) PBMCs will be isolated, frozen in Trizol and shipped to CBER. Plasma will be frozen and shipped to CBER.
0.5 mls for CBCs
Day 0: Vaccinate by the subcutaneous route on the inner thigh of both legs to promote draining of vaccination site to superficial inguinal lymph nodes. Deliver Pentacel to the aP animals and Pentavac SD + IPOL to the wP animals
Day 1: Draw blood
2.5 mls for PaxGene (transcriptomics) 4 mls for PBMCs (transcriptomics) and plasma (antigen ELISAs and banking for proteomics) PBMCs will be isolated, frozen in Trizol and shipped to CBER. Plasma will be
Day 3: Draw blood
4 mls for PBMCs (transcriptomics) and plasma (antigen ELISAs and banking for proteomics)
PBMCs will be isolated, frozen in Trizol and shipped to CBER. Plasma will be
Day 7: Draw blood
4 mls for PBMCs (transcriptomics) and plasma (antigen ELISAs and banking for proteomics) PBMCs will be isolated, frozen in Trizol and shipped to CBER. Plasma will be
Day 18: Draw 4 mls of blood for serum.
Draw 0.5 mls of blood for CBCs
Collect fine needle aspirates from superficial inguinal lymph node from both legs.
Combine the two aspirates, divide into two aliquots, freeze and ship to LJII (Crotty Lab)
Collect bone marrow aspirates for evaluation of trained immunity. Ship fresh overnight to LJII (Sette Lab)
Second Vaccination:
Day 0: Draw blood
2.5 mls for PaxGene (transcriptomics) 4 mls for PBMCs (transcriptomics) and plasma (antigen ELISAs and banking for proteomics) PBMCs will be isolated, frozen in Trizol and shipped to CBER. Plasma will be
0.5 mls for CBC
Vaccinate by the subcutaneous route on the inner thigh of both legs to promote
Day 7: Draw blood
4 mls for PBMCs (transcriptomics) and plasma (antigen ELISAs and banking for proteomics) PBMCs will be isolated, frozen in Trizol and shipped to CBER. Plasma will be
Day 18: Draw 4 mls of blood for serum.
Draw 0.5 mls of blood for CBCs
Collect fine needle aspirates from superficial inguinal lymph node from both legs.
Combine the two aspirates, divide into two aliquots, freeze and ship to LJII (Crotty Lab)
Collect bone marrow aspirates for evaluation of trained immunity. Ship fresh overnight to LJII (Sette Lab)
Third Vaccination:
Day 0: Draw blood
4 mls for serum
Vaccinate by the subcutaneous route on the inner thigh of both legs to promote
Day 18: Draw Blood
8 mls for PBMCs for evaluation of T-cell responses. PBMCs will be isolated on site, stimulated with HKBp or cocktail of antigens and incubated at 37OC in 5% CO2 for 72 hours. An aliquot of each culture supernatant will be analysed by Luminex for a 10-plex cytokine panel. The remaing supernatant will be frozen and shipped to CBER. Plasma will be frozen and sent to CBER for antigen ELISAs and banking for proteomics 8 mls whole blood shipped fresh overnight to LJII (Crotty Lab) for evaluation of memory responses in the periphery.
0.5 mls for CBCs.
Collect bone marrow for evaluation of B-cell and T-cell memory. Ship fresh to CBER overnight.
Collect BAL to quantify Tissue-resident memory cells (TRM) cells. Ship fresh overnight to CBER.
Six Months Post Third Vaccination: Sampling of age-matched, unvaccinated animals selected from the breeding program will begin at this time point.
Draw Blood 8 mls for PBMCs for evaluation of T-cell responses. PBMCs will be isolated on site, stimulated with HKBp or cocktail of antigens and incubated at 37OC in 5% CO2 for 72 hours.
An aliquot of each culture supernatant will be analysed by Luminex for a 10-plex cytokine panel. The remaing supernatant will be frozen and shipped to CBER. Plasma will be frozen and sent to CBER for antigen ELISAs and banking for proteomics 8 mls whole blood shipped fresh overnight to LJII (Crotty Lab) for evaluation of memory responses in the periphery.
Collect bone marrow for evaluation of B-cell and T-cell memory. Ship fresh to CBER overnight.
Collect BAL to quantify Tissue-resident memory cells (TRM) cells. Ship freah overnight to
CBER.
Long-term Analysis:
Following the six-month sampling, blood will be collected twice per year when animals are sedated for semi-annual TB testing. Samples will also be collected from age-matched unvaccinated animals in the colony. Sampling of Convalescent animals will begin with these time points.
Draw Blood 8 mls for PBMCs for evaluation of T-cell responses. PBMCs will be isolated on site, stimulated with HKBp or cocktail of antigens and incubated at 37OC in 5% CO2 for 72 hours.
An aliquot of each culture supernatant will be analysed by Luminex for a 10-plex cytokine panel. The remaing supernatant will be frozen and shipped to CBER. Plasma will be frozen and sent to CBER for antigen ELISAs and banking for proteomics 8 mls whole blood shipped fresh overnight to LJII (Crotty or Sette Lab) for evaluation of memory responses in the periphery.
Collect bone marrow for evaluation of B-cell and T-cell memory. Ship fresh to CBER overnight.
Collect BAL to quantify Tissue-resident memory cells (TRM) cells. Ship fresh overnight to
CBER.
It is anticipated, the study will continue for 4 years from last vaccination but may be continued based on results.
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