Timeline of malaria vaccine

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This is a timeline of malaria vaccine, attempting to describe its development. "Malaria is the most important parasitic disease of humans and efforts to develop effective vaccines span more than six decades"[1]

Big picture

Year/period Key developments
1960s "Modern malaria vaccine development stems from immunization studies of mice with irradiated sporozoites, conducted in the 1960s [10], and subsequent analyses of the mechanisms of immunity in this model [11]."[1]

Full timeline

Year/period Type of event Event Location
1942 Studies of inactivated sporozoite immunization show apparently beneficial effect of combining induction of cellular and humoral immune responses against malaria of domestic fowl.[1]
1967 Research on avian malaria shows that killed sporozoites as well as sporozoites inactivated with ultraviolet light can produce a partial immunity after injection into birds.[2][3]
1970 Research reveals immune cross protection against malaria in rodent systems.[4]
1983 The first publications for cloning malaria antigens appear.[3]
1984 The Walter Reed Army Institute of Research (WRAIR) and British pharmaceutical company GlaxoSmithKline (GSK) initiate collaboration to produce a malaria vaccine using GSK’s recombinant Escherichia coli expression systems. [5][6]
1987 Researchers working at GlaxoSmithKline’s (GSK) laboratories, develop RTS,S malaria vaccine candidate (Mosquirix TM).[5] It is the first vaccine created by combining the malaria CS protein and hepatitis B surface antigen.[5] United Kingdom
1995 Trial First RTS,S clinical tests in humans are conducted in adults in the United States.[5] United States
1997 "RTS,S" "Key proof-of-concept (PoC) study shows 6 of 7 volunteers in challenge trial are 100% protected."[5]
1998 Trial First RTS,S trials in Africa are conducted in Gambia.[5] Gambia
1999 Program launch The PATH Malaria Vaccine Initiative (MVI) is established, with aims at accelerating the development of malaria vaccines and catalyzing timely access in endemic countries. [7][8]
2001 The GSK/MVI partnership (GlaxoSmithKline and PATH Malaria Vaccine Initiative (MVI)) initiates, with grants from the [[wikipedia:Bill & Melinda Gates Foundation|Bill & Melinda Gates Foundation to PATH, with aims at developing RTS,S for infants and young children living in malaria-endemic regions in Sub-Saharan Africa."[5]
2004 "Koy PoC study in children in the Mozambique"[5]
2006 The Malaria Vaccine Technology Roadmap launches.[9][10]
2007 "Phase II results in African children and infants published in the LANCET and NEJM"[5]
2009 Trial "RTS,S" "Phase III study start"[5] "GlaxoSmithKline Biologicals' (GSKBio) RTS,S" "A Phase III trial of the world’s most clinically advanced malaria vaccine candidate was launched in Kisumu, Kenya, in July 2009, under the auspices of the Kenya Medical Research Institute (KEMRI)/CDC Research and Public Health Collaboration."[11] "The RTS,S Phase III efficacy and safety trial—the largest malaria vaccine trial in Africa to date—beganin May 2009 and ended in early 2014. The trial involved 15,459 infants and young children at 11 sites in seven African countries(Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, and Tanzania)."[7][12]
2011 Trial "The RTS,S vaccine was tested in Phase III trials in 11 different African countries. These trials have had some successes. The earliest results, released in October 2011, showed that in children aged 5-17 months, vaccination with RTS,S reduced the risk of clinical malaria and severe malaria by 56% and 47%, respectively.[17] However, in results released in November 2012, the vaccine was less effective in infants aged 6-12 weeks at first vaccination."[13]
2013 "Malaria Vaccine Technology Roadmap (launched in 2006) has been updated in November 2013. The updated Roadmap represents a blueprint for second generation malaria vaccine development, including a new Vision, two new Strategic Goals and 13 priority activities"[9]
2014 " The phase-III randomized trials of RTS,S vaccine recruited 15,459 infants (aged 6 to 12 weeks) and children (aged 5 to 17 months), from 11 study sites with unique malaria transmission across 7 sub-Saharan African countries such as Kenya, United Republic of Tanzania, Malawi, Gabon, Mozambique, Burkina Faso, and Ghana. In 2014, initial phase- III result at 18 months of trial introduction showed the vaccine efficacy of 46% in children and 27% among young infants against the clinical malaria"[14]
2015 (July) "The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced on July 24, 2015,that it has adopted a positive scientific opinion, under Article 58, for GSK’s malaria candidate vaccine Mosquirix TM, also known as RTS,S, in children aged 6 weeks to 17 months."[5][15]
2016 "The January 2016 WHO position paper that followed the CHMP opinion endorses the recommendations made by the WHO Strategic Advisory Group of Experts (SAGE)on Immunization and Malaria Policy Advisory Committee (MPAC) in October 2015. According to the position paper, “WHO recommends that the pilot implementations use the 4-dose schedule of the RTS,S/AS01 vaccine in 3–5 distinct epide

miological settings in sub-Saharan Africa, at subnational level, covering moderate-to-high transmission settings,”with three doses administered to children between 5 and 9 months of age, followed by a fourth dose 15–18 months later."[7][15]

2016 "17 November 2016, WHO announced that the RTS,S vaccine would be rolled out in pilot projects in 3 countries in sub-Saharan Africa. The pilot programme, coordinated by WHO, will assess the extent to which the vaccine’s protective effect shown in advanced clinical trials (referred to below as “Phase 3 trials”) can be replicated in real-life settings. Specifically, the programme will evaluate the feasibility of delivering the required 4 doses of the vaccine; the impact of the vaccine on lives saved; and the safety of the vaccine in the context of routine use. "[15]

See also

References

  1. 1.0 1.1 1.2 "Vaccines against malaria". royalsocietypublishing.org. Retrieved 18 April 2017. 
  2. "Protective Immunity produced by the Injection of X-irradiated Sporozoites of Plasmodium berghei". nature.com. Retrieved 18 April 2017. 
  3. 3.0 3.1 "Malaria Vaccine Design: Immunological Considerations". sciencedirect.com. Retrieved 18 April 2017. 
  4. Peters, Wallace. Antimalarial Drugs I: Biological Background, Experimental Methods, and Drug Resistance. Retrieved 19 April 2017. 
  5. 5.00 5.01 5.02 5.03 5.04 5.05 5.06 5.07 5.08 5.09 5.10 "Fact s heet: T he RTS,S malaria vaccine candidate (Mosquirix TM )" (PDF). Retrieved 17 April 2017. 
  6. Ripley Ballou, W.; Cahill, Conor P. "Two Decades of Commitment to Malaria Vaccine Development: Glaxosmithkline Biologicals". Retrieved 19 April 2017. 
  7. 7.0 7.1 7.2 "Fact sheet: R TS,S malaria vaccine candidate (Mosquirix™)" (PDF). malariavaccine.org. Retrieved 17 April 2017. 
  8. "Malaria Vaccine Initiative". inyvax.eu. Retrieved 18 April 2017. 
  9. 9.0 9.1 "Immunization, Vaccines and Biologicals". who.int. Retrieved 17 April 2017. 
  10. "Malaria vaccine technology roadmap". doi:http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)62238-2/fulltext Check |doi= value (help). Retrieved 18 April 2017. 
  11. "Malaria Vaccine". cdc.gov. Retrieved 17 April 2017. 
  12. "Advances and challenges in malaria vaccine development". PMC 2994342Freely accessible. doi:10.1172/JCI44423. Retrieved 17 April 2017. 
  13. "Malaria and Malaria Vaccine Candidates". historyofvaccines.org. Retrieved 17 April 2017. 
  14. "Malaria Vaccine Development: Recent Advances alongside the Barriers". omicsonline.org. Retrieved 18 April 2017. 
  15. 15.0 15.1 15.2 "Questions and answers on RTS,S/ASO1 malaria vaccine". who.int. Retrieved 17 April 2017.