Moving the Needle: September 2022 news from PATH on vaccine development

 

News from PATH on vaccine development
 

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September 2022  |  Subscribe

 
 

 

     
 

In this issue

Farewell and thank you to the Global Head of CVIA

Monoclonal antibody shows promise in preventing malaria

Universal reagent development for sIPV D antigen

Early closure of pivotal Phase 3 study of injectable rotavirus vaccine candidate

Q & A with John Tanko Bawa

Clinical updates

Resources and opportunities

 
   
     

Farewell and thank you to the Global Head of CVIA

David Kaslow, PATH’s Chief Scientific Officer and Global Head of PATH's Center for Vaccine Innovation and Access (CVIA), has been named the Director of the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research, an agency within the United States Food and Drug Administration. We thank him for his leadership and decade-long tenure at PATH where he led work to accelerate the development and introduction of lifesaving vaccines for the women, children, and communities around the world who need them most. PATH will conduct a competitive, global recruitment for the Chief Scientific Officer position. Candidates based in the African and Asian continents will be given priority. Watch the PATH Careers website for the job posting.

 

Monoclonal antibody shows promise in preventing malaria

Positive results from a first-in-human clinical trial of a monoclonal antibody (mAb), TB31F, designed to block transmission of the Plasmodium falciparum malaria parasite from humans to mosquitoes, were recently published in The Lancet Infectious Diseases. The study, conducted at Radboud University Medical Center in Nijmegen, the Netherlands, showed that serum taken from individuals given the highest concentration of TB31F mAB fully prevented transmission of the parasite to mosquitoes for three months (the end of the follow-up period). The mAb was safe and well tolerated in all administered dosages and was shown to be potent in preventing transmission at very low antibody concentrations. If these results are confirmed in future field trials, this or a similar mAb could be a promising tool for deployment in areas of seasonal malaria transmission. The study enrolled 25 healthy adult volunteers grouped across five study arms using various dosages of TB31F.

In related news, PATH received a grant from the Global Health Innovative Technology Fund in Japan for preclinical development of a different mAb targeting the circumsporozoite protein on the P. falciparum parasite to block infection in humans. This is a collaboration with GlaxoSmithKline (GSK), Ehime University in Japan, and Esai Co., Ltd. (a Japanese pharmaceutical company). image

Universal reagent development for sIPV D antigen

In August, PATH hosted a global workshop with vaccine manufacturers, regulators, and other key stakeholders to discuss the results of a global collaborative study aimed at identifying a set of universal reagents for the Sabin inactivated polio vaccine (sIPV) development process. This effort follows previous work that drove the development and endorsement of an International Standard for sIPV D antigen potency by the World Health Organization (WHO) in 2018. The recommended universal reagents will undergo further evaluation based on results from the collaborative study, and WHO is expected to review and endorse the set of universal reagents for sIPV later this year. image

Early closure of pivotal Phase 3 study of injectable rotavirus vaccine candidate

PATH and partners have been evaluating the safety, immunogenicity, and efficacy of an injectable non-replicating rotavirus vaccine (NRRV) candidate in a Phase 3 study in infants at clinical sites in Ghana, Malawi, and Zambia. The trial aimed to determine how well the vaccine candidate prevents rotavirus diarrhea in infants compared to a licensed oral rotavirus vaccine. Following an interim analysis, the study’s independent Data Safety and Monitoring Board (DSMB) determined that the trial should not continue as planned. There is insufficient evidence that the NRRV vaccine candidate provides superior protection compared to a licensed oral rotavirus vaccine. PATH is working to implement the DSMB’s recommendations after which the study will close, as well as to identify possible reasons why the candidate did not perform as expected. image
 
 

 

Interview

Q & A with John Tanko Bawimage

John Tanko Bawa, CVIA’s Team Lead for Vaccine
Implementation in Africa,
discusses the significanc
of recent RTS,S/AS01 (RTS,S) malaria vaccine milestones following the 2021 WHO recommendation and work to optimize the use of this vaccine.

 

Q: What is the significance of WHO prequalification for RTS,S?

A: WHO prequalification is a critical step in expanding access. This designation allows UNICEF to purchase RTS,S, and Gavi, the Vaccine Alliance, to provide financial assistance to eligible countries. Gavi recently opened a US$155.7 million funding window to support the introduction of malaria vaccines in eligible countries between 2022 and 2025.

 

Q: What is the next step for this vaccine?

A: We expect to see its use expand in the three countries participating in the pilot introduction of RTS,S—Ghana, Kenya, and Malawi—thanks to a recent grant from Open Philanthropy to PATH. This expansion will make the vaccine available to children in pilot areas not previously eligible. Other countries will start submitting applications to Gavi starting in January 2023 to introduce the vaccine.

 

Q: What else is PATH doing with RTS,S?

A: We are supporting research to continue learning how best to use and deploy RTS,S, including in highly seasonal malaria settings. We have learned that targeted immunization aligned with peak transmission season combined with seasonal malaria drugs can have profound effects. We’re also working with GSK and partners in Ghana and Kenya on a fractional dosing study to see if we can make the doses we have go further. In partnership with several academic and research institutes, we’re also working to identify immune correlates of protection for malaria vaccines using data from RTS,S clinical trials.

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Clinical updates

September 2022

A Phase 3 trial (PACTR202112680671189) evaluating the safety, immunogenicity, and non-inferiority of multi-dose and single-dose vial formulations of a typhoid conjugate vaccine (TCV) candidate, EuTCV, compared to a licensed TCV began enrollment at a second site in Kericho, Kenya. The first site, in Sandiara, Senegal, began enrollment in May 2022. A total of 3,255 participants aged 6 months to 45 years will be enrolled across both clinical sites.  

 

 
 

 

Resources and opportunities

New and updated resources

COVID-19 maternal immunization resource library website

Four ways PATH is hastening polio eradication web article

Human papillomavirus vaccine cost calculator

Latest childhood immunization data must spur renewed action web article

Mapping the current state of vaccine production infrastructure in Africa

Rotavirus vaccine cost calculator

RSV clinical trial tracker

RSV vaccine and mAb snapshot

Pakistan’s TikTok campaign for COVID-19 information web article

Pneumococcal conjugate vaccine cost calculator

Vaccine manufacturing: On the critical path to vaccine access fact sheet

 

New scientific publications

Concordance of in vitro and in vivo measures of non-replicating rotavirus vaccine potency

The cost-effectiveness of human papillomavirus vaccination in the Philippines

COVID-19: How is the pandemic changing the vaccines space?

How can we prevent cervical cancer in Mongolia?

The potential cost-effectiveness of HPV vaccination among girls in Mongolia

Respiratory syncytial virus prevention within reach: The vaccine and monoclonal antibody landscape

 
 

CVIA at upcoming events

12th International Respiratory Syncytial Virus Symposium
September 29 to October 2
Belfast, Northern Ireland, UK

American Society of Tropical Medicine & Hygiene Annual Meeting
October 30 to November 3
Seattle, WA

Vaccines Against Shigella and Enterotoxigenic Escherichia coli Conference
November 29 to December 1
Washington, D

CVIA job opportunities

Program officer, vaccine implementation

Senior program assistant

Technical program advisor, CMC

 
 

 

PATH’s Center for Vaccine Innovation and Access brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world.

 

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