Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Investigational Malaria Vaccine Found Safe and Protective

Published: Friday, August 09, 2013
Last Updated: Friday, August 09, 2013
Bookmark and Share
An investigational malaria vaccine has been found to be safe, to generate an immune system response, and to offer protection against malaria infection in healthy adults.

The vaccine, known as PfSPZ Vaccine, was developed by scientists at Sanaria Inc., of Rockville, Md. The clinical evaluation was conducted by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and their collaborators at the Walter Reed Army Institute of Research, Silver Spring, Md., and the Naval Medical Research Center, Bethesda, Md.

Malaria is transmitted to humans by the bite of an infected mosquito. After the bite occurs, infectious malaria parasites in the immature, sporozoite stage of their life cycle first travel to the liver, where they multiply, and then spread through the bloodstream, at which time symptoms develop.

The PfSPZ Vaccine is composed of live but weakened sporozoites of the species Plasmodium falciparum, the most deadly of the malaria-causing parasites.

“The global burden of malaria is extraordinary and unacceptable,” said NIAID Director Anthony S. Fauci, M.D. “Scientists and health care providers have made significant gains in characterizing, treating and preventing malaria; however, a vaccine has remained an elusive goal. We are encouraged by this important step forward.”

The Phase I trial, which took place at the NIH Clinical Center in Bethesda, received informed consent from and enrolled 57 healthy adult volunteers ages 18 to 45 years who never had malaria. Of these, 40 participants received the vaccine and 17 did not. To evaluate the vaccine’s safety, vaccinees were split into groups receiving two to six intravenous doses of PfSPZ Vaccine at increasing dosages. After vaccination, participants were monitored closely for seven days. No severe adverse effects associated with the vaccine occurred, and no malaria infections related to vaccination were observed.

Based on blood measurements, researchers found that participants who received a higher total dosage of PfSPZ Vaccine generated more antibodies against malaria and more T cells — a type of immune system cell — specific to the vaccine.

To evaluate whether and how well the PfSPZ Vaccine prevented malaria infection, each participant — the vaccinees as well as the control group that did not receive vaccine – was exposed to bites by five mosquitoes carrying the P. falciparum strain from which the PfSPZ Vaccine was derived. This controlled human malaria infection procedure — a standard process in malaria vaccine trials — took place three weeks after participants received their final vaccination. Participants were monitored as outpatients for seven days and then admitted to the NIH Clinical Center, where they stayed until they were diagnosed with malaria, treated with anti-malarial drugs and cured of infection, or shown to be free of infection.

The researchers found that the higher dosages of PfSPZ Vaccine were associated with protection against malaria infection. Only three of the 15 participants who received higher dosages of the vaccine became infected, compared to 16 of 17 participants in the lower dosage group who became infected. Among the 12 participants who received no vaccine, 11 participants became infected after mosquito challenge.

“In this trial, we showed in principle that sporozoites can be developed into a malaria vaccine that confers high levels of protection and is made using the good manufacturing practices that are required for vaccine licensure ,” said Robert A. Seder, M.D., chief of the Cellular Immunology Section of the NIAID Vaccine Research Center and principal investigator of the trial.

An important challenge in the continued development of PfSPZ Vaccine is that the vaccine currently is administered intravenously — a rare delivery route for vaccines. Previous studies at lower doses have shown that the more common intradermal (into the skin) and subcutaneous (under the skin) routes did not yield as strong an immune response as the intravenous route.

“Despite this challenge, these trial results are a promising first step in generating high-level protection against malaria, and they allow for future studies to optimize the dose, schedule and delivery route of the candidate vaccine,” said Dr. Seder.

A number of follow-up studies are planned, including research to evaluate the vaccine’s different dose schedules, possible protection against other Plasmodium strains and the durability of protection. The researchers may also evaluate whether higher doses administered subcutaneously or intradermally provide the same level of protection as that found in this study.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
Biomolecular Manufacturing ‘On-the-Go’
Wyss Institute team unveils a low-cost, portable method to manufacture biomolecules for a wide range of vaccines, other therapies as well as diagnostics.
Molecular Switch Aids Immune Therapy
Researchers identify strategy to maximise effectiveness of immune therapy through molecular switch controlling immune suppression.
Novavax RSV F Vaccine Fails Phase 3 Trial
Novavax announces topline RSV F Vaccine data from two clinical trials in older adults.
GSK’s Shingles Vaccine Candidate Shows High Efficacy
The vaccine candidate showed high efficacy against shingles and its complications in adults aged 70yrs+ in phase III study.
Eisai Establishes AiM Institute
The Andover innovative Medicines (AiM) Institute will develop innovative precision medicines for hard-to-treat conditions.
Antibodies that Target Holes in HIV's Defence Identified
Scientists suggest 'holes' in HIV sugar sheild can be targeted by antibodies.
Discovery Could Yield Improved Flu Vaccines
Researchers have discovered a type of immune antibody that can evolve to combat a number of infuenza virus strains.
First Accurate Simulation of a Virus Invading a Cell
For the first time, scientists know what happens to a virus’ shape when it invades a host cell.Understanding how the virus shape specifically changes could lead to more effective anti-viral therapies.
Developing a Vaccine for Sexually Transmitted and Insect-Borne Zika Infections
Prokarium announce the beginning of a programme to develop an oral vaccine against Zika infection.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!