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

 

News from PATH on vaccine development
 

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June 2022  |  Subscribe

 
 

 

     
 

In this issue

Typhoid conjugate vaccine candidate aims to increase global supply

Register and submit an abstract for VASE 2022!

New online library supports maternal immunization for COVID-19 and beyond

Q & A with John Konz

Clinical updates

Resources and opportunities

 
   
     

Typhoid conjugate vaccine candidate aims to increase global supply

A Phase 3 study of a new typhoid conjugate vaccine (TCV) candidate called EuTCV began enrollment in Sandiara, Senegal, in early May after site initiation on April 29, 2022. PATH is working with the Institut de Recherche en Santé de Surveillance Epidemiologique et de Formation, Senegal, and vaccine manufacturer EuBiologics to assess the safety and immune response of EuTCV in adults and young children older than six months of age. In the coming months, the trial will be expanded to a second site in Kericho, Kenya, in partnership with the Kenya Medical Research Institute-Kericho and Walter Reed Army Institute for Research. The multicenter trial will last two years.

EuBiologics will concurrently seek to have EuTCV prequalified by the World Health Organization (WHO) so that it may be acquired for subsidized use in low-income countries. The results from this study will help meet post-prequalification data requirements that would enable EuTCV to join the list of TCVs that are already globally available. The development and approval of additional TCV products has the potential to increase supply, reduce costs, and improve availability of these lifesaving vaccines. PATH also supports country TCV decision-making and introduction as a core member of the Typhoid Vaccine Acceleration Consortium.

 

Register and submit an abstract for VASE 2022!

Registration is now open for PATH’s third international Vaccines Against Shigella and enterotoxigenic Escherichia coli (VASE) Conference, which will be held November 29 to December 1, 2022 in Washington, DC. This year’s conference will encompass three full days and is being planned as a fully in-person event. VASE 2022 will also have an expanded scope that includes other emerging pathogens, such as Campylobacter and non-typhoidal Salmonella, as important contributors to the global diarrheal disease burden.

Researchers working in these areas are encouraged to submit their work to be considered for presentation at VASE. While the deadline for regular abstract submissions is today, June 7, 2022, late-breaking abstract submissions will also be accepted. In addition, PATH is offering a limited number of travel grants to people who need financial assistance to attend VASE 2022. Late-breaking abstracts and travel grant applications must be submitted by August 9, 2022. image

New online library supports maternal immunization for COVID-19 and beyond

The COVID-19 pandemic has triggered increased public health attention on advancing vaccination in pregnancy and a need for easily accessible key information as the landscape rapidly changes. To address this need, PATH is hosting the COVID-19 Maternal Immunization Resource Library developed in collaboration with WHO. This one-stop hub connects decision-makers, implementers, advocates, and others to the latest public health information related to COVID-19 vaccines, pregnancy, and breastfeeding.

COVID-19 increases the risk of health complications in pregnancy such as severe illness for pregnant individuals and adverse birth outcomes for newborns. Maternal immunization is a powerful public health tool—however vaccination in pregnancy is not used to its full potential as an essential health service, nor against COVID-19 (despite WHO’s interim recommendations that it should be). Updated quarterly, the new library will be an asset for stakeholders planning and advancing maternal immunization strategies for the current COVID-19 pandemic as well as for broader, cross-pathogen disease prevention. image

 
 

 

IntervieW

Q & A with John Konz


npj Vaccines recently published a manuscript co-authored by PATH staff onimage evaluating the stability of attenuated Sabin and two novel type 2 oral poliovirus vaccines in children. Dr. John Konz, one of the co-authors and novel oral polio vaccine against type 2 (nOPV2) project director, discusses the findings. Q: Why is this a significant milestone for nOPV2?

A: This publication is the first evidence showing that the attenuation of nOPV2 is more stable than the current vaccine—its key differentiating factor—in children younger than five years old, the intended population.

Q: Why is attenuation a key focus for nOPV2?

A: The attenuated Sabin OPV strains rapidly evolve, losing much of their attenuated nature over a few weeks of replication. If vaccine coverage is low and the virus transmits from person to person, this can lead to an outbreak. The design goal of nOPV2 was to make this reversion to virulence much less likely.

Q: How did the study evaluate stability?

A: The study compared shed nOPV2 virus with shed Sabin OPV2 virus in stool samples and found that the nOPV2 shed virus was significantly less neurovirulent. Additionally, deep sequencing analysis showed that the primary site of attenuation for nOPV2 was genetically stable, unlike Sabin OPV2. These data prompted key decision-makers to approve use of nOPV2 under an Emergency Use Listing (EUL). We expect to see a substantial reduction in the frequency of disease caused by regained vaccine virus virulence that, while rare, is associated with widespread Sabin OPV2 use.

Q: What’s next for nOPV2?

A: We expect data showing similar findings in infant cohorts to be published soon. Additionally, data from the nOPV2 deployments under EUL and from additional clinical studies will feed into the application for full licensure and WHO prequalification next year. Learn more about the nOPV2 development effort.

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Clinical updates

April 2022

  • A Phase 2 trial (NCT0434405) evaluating the safety and immunogenicity of different combinations and schedules of oral and injected rotavirus vaccines and vaccine candidates completed the enrollment of 850 infants at two sites in South Africa.
  • A controlled human infection model (CHIM) challenge/rechallenge trial (NCT04992520) was initiated in Baltimore, Maryland, to study two Shigella challenge strains: S. sonnei strain 53G and S. flexneri 2a strain 2457T. The CHIM study will enroll about 80 healthy adults and aims to determine if challenging volunteers with one species of Shigella will induce some cross-protective immunity when a subset of volunteers is challenged later with the second strain.
 
 

 

May 2022

  • A follow-on study to the Phase 3 trial evaluating the RTS,S/AS01E (RTS,S) malaria vaccine in comparison to and in combination with seasonal malaria chemoprevention (SMC) in Burkina Faso and Malawi (NCT04319380) started its second year. This follow-on study will examine, by passive surveillance and case control studies, whether children who received both RTS,S and SMC during the Phase 3 trial and who experienced less clinical malaria during the trail, may have less naturally acquired protection against malaria.
  • A Phase 3 trial (PACTR202112680671189) evaluating the safety (in participants aged 6 months to 45 years) and non-inferiority (in participants aged 9 to 12 months) of multi-dose and single-dose vial formulations of EuTCV (Vi-CRM197 TCV) against Typbar TCV® (a licensed TCV) began enrollment in Sandiara, Senegal. The trial is also evaluating lot-to-lot consistency of the immune response to the multi-dose vial formulation of EuTCV in healthy participants 9 to 12 months of age.
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Resources and opportunities

New and updated resources

COVID-19 maternal immunization resource library website

Expanding the impact of COVID-19 vaccine rollout web article

Global access training for Chinese COVID-19 vaccine developers web page

Human papillomavirus vaccine cost calculator

Malawi’s village volunteers go door-to-door with vaccine messages web article

National introduction of HPV vaccination in low- and middle-income countries: Lessons learned from formal post-introduction evaluations

The RTS,S malaria vaccine fact sheet

The switch from ROTARIX to ROTAVAC in Ghana: Answers to four key questions case study

Vaccinating 65,000 people in two days web article

The world’s first malaria vaccine and beyond web article

Zero-dose children: Reaching the unreached web article

New scientific publications

Delayed fractional dosing with RTS,S/AS01 improves humoral immunity to malaria via a balance of polyfunctional NANP6- and Pf16-specific antibodies

Evaluating stability of attenuated Sabin and two novel type 2 oral poliovirus vaccines in children

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

Potential impact and cost-effectiveness of injectable next-generation rotavirus vaccines in 137 LMICs: A modelling study

Safety and immunogenicity of an inactivated recombinant Newcastle disease virus vaccine expressing SARS-CoV-2 spike: Interim results of a randomised, placebo-controlled, Phase 1 trial

What drives the value of a Shigella vaccine?

 

 
 

 

CVIA at upcoming events

12th International Symposium on Pneumococci and Pneumococcal Diseases
June 19 to 23
Toronto, Canada/Virtual

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

 

CVIA job opportunities

Advocacy and communications officer

Senior commercialization officer

Senior project administrator

Technical program advisor

 
 

 

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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