UNC Project To Conduct HIV Vaccine Tests in Malawi

Professor Francis Martinson 

After success in conducting Malaria candidate vaccine for children waiting approval from World Health Organization, the UNC Project in Malawi is planning to carry out tests of HIV vaccine.

Professor Francis Martinson the UNC Project Country Director, disclosed that the study only awaits an approval of their application by the National Health Sciences Research Committee.

He said once the committee give a go ahead, tests will be carried out in areas where there is high HIV prevalence and that trials will target close to 20 adults with low risk of HIV.

With all support, Martinson said those participants will be followed up for the rest of their lives to see how the vaccine behaves in their body.

He offered hope that once the results of the study brings out positive result, there is possibility of trying the vaccine to those infected with HIV Virus.

Prof. Martinson made emphasis that this HIV Vaccine study aims at adding force to existing tools for fighting HIV prevalence.

"HIV prevalence remains at 10% for quite some time now, so we need more tools to force down the prevalence. That is why the issue of HIV Vaccine comes in." he said

He explained that the vaccine which is not an infectious agents, once introduced in the normal body will trick the body to produce antibodies that can be ready to fight and kill the virus so that the body does not get infected.

But he urged people to be part of the trial process "Everybody needs to do their portion. You need to be part of the process." Urged Prof. Martinson

"If we test the HIV virus in your country is easy to do a vaccine and the chances that the vaccine will work better in your country are far better than if we go and test those vaccines in another country and bring the results here.

It is always good to participate in some of these things so that you reap the full benefits of the results of these studies" explained Martinson

The UNC Project country director hinted that many SADC region countries where HIV prevalence is very high including South Africa, Botswana and Zambia are also participating in this vaccine.

"In these places people have higher chances of being exposed to HIV virus. The Vaccine is being tested in these areas because they are people who will benefit most with the vaccine."

UNC Project in Malawi was also recently involved in trials for malaria candidate vaccine for children (RTS, S/ Mosquirix) which will soon be recommended by World Health Organisation. The Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency has already made a positive opinion of the vaccine.

Important facts

Prof. Martinson has emphasized that the project will be looking at possibility of testing the HIV Vaccine in a small section of the population to see how it works. And if the vaccine is able to demonstrate that it works adequately, UNC Project will be able to tweak where little inefficiency are and then scale up the vaccination to a bigger group to see really what happens in a population if it’s possible.



He indicated that this vaccine is not an infectious agents. But Said this Vaccine only has part of the virus that causes the body to react and produce antibodies but cannot infect the body. So it will just trick the body to produce antibodies which normally when somebody gets infected those antibodies should be ready to fight the virus which has been introduced and kill them so that that person does not get infected.



The vaccine wants to prevent people from the virus so the people to be vaccinated are those that are not infected so are not taking medications



“We need to try this to someone who is normal first so that once we know the body is reacting right then we can go to somebody who has either been infected depending on type of the vaccine that we will be using, or pre use it to prevent everybody who has not been exposed” explained Prof. Martinson



“May be somewhere along the line when we have seen how it behaves in normal people it may be possible to look to see those people who are already infected and are taking medication if the vaccine is going to be of any use to them also to help them fight the virus.” he said

Malaria Vaccine RTS,S Receives Positive Opinion From European Regulators

Malaria candidate vaccine ‘Mosquirix’ RTS, S receives positive opinion from European regulators. This is a milestone in the fight against malaria in Sub-Saharan Africa.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive scientific opinion for Mosquirix’ RTS, S,  which trigger the body’s immune system to defend against the malaria parasite among children aged 6 weeks to 17 months. 

Prof. Francis Martinson

UNC Project Country Director, Prof. Francis Martinson, also the Principle Investigator for the vaccine trial in Malawi, says “We have played one of the biggest headways” 

Prof. Martinson said the opinion from CHMP of the EMA made on 24th July, 2015 agrees that the vaccine is good enough to be used “everywhere” where there is malaria transmission. 

He said the Mosquirix’ RTS, S, S is a noticeable milestone and a plus for number of existing malaria prevention tools that includes bed nets and sanitation as this vaccine will hopefully increase the efficacy of prevention programmes so that less people get infected with Malaria.

“We strongly believe that as fewer and fewer people have the parasite in them then the eventual dream of having eradication of malaria will come true.” He said

A lot of people die of Malaria in sub-Saharan Africa (SSA). In 2013, there were an estimated 584,000 deaths with around 90 percent of these occurring in SSA, and 83 percent in children under the age of five in SSA.

“If you visit any hospital during the malaria season, many of the cases that the clinicians are seeing or are on admission are malaria cases. So if we can prevent that many from appearing in the hospital, that will be a lot of time for the doctors and nurses to provide a better care to those who find themselves in the hospital.” Added Prof. Martinson 

Prof. Martinson further said, following this positive opinion, the documentation has been forwarded to Word Health Organisation (WHO) whose committees will also look at the information.

“Once they will agree which we hope will be before the end of the year, we will see a report from them that will eventually lead to request various national regulatory authorities to start looking at possibility of including the vaccine in their vaccination programmes” he said

The UNC Project Country Director said for now, the vaccine is for the children since were targeted in the trial due to frequent cases among them.

But he expressed hope that once the vaccine minimizes the problem in the children there will be another clinical trial for adults. 

“We are already in contact with sponsors about the possibility of doing this study again in adolescent and adults.” He disclosed

The positive opinion for young children was based on the review of data assessing the candidate vaccine’s safety, efficacy and quality from a Phase III clinical trial programme involving more than 16,000 young children that was conducted by 13 African research centres in eight African countries including Malawi at Area 18 Health Centre in Lilongwe.

Data from this Phase III clinical trial programme demonstrate that over the first 18 months following three doses of RTS,S, malaria cases were reduced by almost half in children aged 5-17 months at the time of first vaccination and by 27% in infants aged 6-12 weeks. 

At study end, four doses of RTS,S reduced malaria cases by 39% over four years of follow-up in children, and by 27% over three years of follow-up in infants. In areas of the highest malaria burden more than 6,000 clinical malaria cases were prevented over the study period for every 1,000 children vaccinated.

RTS, S Malaria Vaccine Candidate Study Shows Success

Malawi team in Malaria vaccine study

A study on Malaria vaccine candidate has registered positive results, now thought to be a break through in the fight against Malaria in endemic regions in sub-Saharan Africa.

Final results from a large-scale Phase III trial of the RTS, S Malaria vaccine candidate including a booster dose shows that it can protect children and infants from clinical malaria for at least three years after first vaccination. 

Eleven research centres in 7 African countries including Area 18 Health Centre in Lilongwe conducted the efficacy and safety trial where the evaluation was in the context of the existing malaria control measures such as incectcide treated bed nets which were used by approximately 80% of the 15, 459  participants.

Prof. Francis Martinson

A Principle Investigator in the trial in Malawi, who is also UNC Project Country Director, Professor Francis Martinson says the latest results to the end of study demonstrates that RTS, S followed by a booster dose of RTS, S administered 18 months after primary schedule, reduced number of cases of clinical malaria in children aged 5-17 months by 36% and by 26% to Infants aged 6-12 weeks.

However without a booster dose the reduction in clinical malaria cases were between 28% and 18% in children and infants respectively.

"Today we have a vaccine which has shown to be effective in one way or the other, the vaccine had showed the efficacy of 36% in the order age group of 5 to 17 months so we are very happy because this is the first time that a vaccine has show some efficacy said Prof. Martinson who added that this is a progress and it is a first vaccine against the parasite."

"We believe this is a beginning of something big, we believe that this is a beginning is something good thats the vaccine hopefully will be improved over the years for us to also have something that works better than something we have seen."

Prof. Francis Martinson
(second from left) Next to him 
is Dr. Portia Kamthunzi 
(a Lead Physician/ Investigator 
of Records

On the recorded percentage efficacy against severe malaria to the end of the study period wich did not even reach 50%, he said If we look carefully the 36% sounds small but this is on top of 80% of bed net usage and that translates to 1774 cases of malaria prevented per every 1000 children. So it looks small but to have over a thousand cases of malaria prevented for every thousand people or children is not a mean achievement. It means at least everybody has been spared in one episode of going to the hospital and therefore the mother of that child is in a great relief because we all know what it means to get malaria and how our mothers suffer through the process for these kids.

Currently the data has been passed on to the European Medicines Agency, where they are looking at it and if they are happy with it they will refer the information to the WHO, who will also look at the results. 

"If the WHO will be happy with the information hopefully they will recommend to African governments to include the vaccine in their EPI programmes." said Prof. Francis Martinson

It is intended to complement and not supplement other malaria control interventions.

The results are important as infants are considered to be the primary target for RTS, S immunisation.

The Sumary details of the research 

Prof. Francis Martinson (middle) and Dr. Portia
Kamnthunzi to his right 

We are pleased to announce that the Final results from a large-scale Phase III trial of the RTS, S malaria vaccine candidate, including the impact of a booster dose, show that the vaccine candidate helped protect children and infants from clinical malaria for at least three years after first vaccination.

The latest results demonstrated that vaccination with RTS,S, followed by a booster dose of RTS,S administered 18 months after the primary schedule, reduced the number of cases of clinical malaria in children (aged 5-17 months at first vaccination) by 36% to the end of the study and in infants (aged6-12 weeks at first vaccination) by 26% to the end of the study. Efficacy decreased over time in both age groups. Without the booster dose, the vaccine reduced clinical malaria cases by 28% in children and 18% in infants to the study end. The efficacy of RTS,S was evaluated in the context of existing malaria control measures, such as insecticide treated bed nets, which were used by approximately 80% of the children and infants in the trial.

For children in the 5-17 month age category who received a booster dose, an average of 1,774 cases of clinical malaria were prevented for every 1,000 children vaccinated across the trial sites, at the end of the study. For infants aged 6-12 weeks age category, who received a booster dose, 983 cases of clinical malaria, on average, were prevented for every 1,000 infants vaccinated. More cases were averted in areas of higher malaria transmission. In the absence of a booster dose, 1,363 cases of clinical malaria were prevented, on average, for every 1,000 children aged 5-17 months and 558 cases for every 1,000 infants aged 6-12 weeks at first vaccination to the end of the study.

Statistically significant efficacy against severe malaria to the end of the study period was observed only in children who received the booster dose. There was indication of increased risk for severe malaria in children who did not receive the booster dose, compared to those in the control group.

Eleven research centres in seven African countries conducted the efficacy and safety trial, in partnership with GSK and the PATH Malaria Vaccine Initiative (MVI), with grant funding from the Bill & Melinda Gates Foundation to MVI. The trial, started in March 2009 and concluded in January 2014, enrolled 15,459 participants, in two age categories: children (aged 5-17 months at first vaccination) and infants (aged 6-12 weeks at first vaccination).

Safety

RTS,S continued to display an acceptable safety and tolerability profile during the entire study period. 

The incidence of fever in the week after vaccination was higher in children who received RTS,S than in those receiving control vaccine. In some children who experienced fever, the febrile reaction was accompanied by generalized convulsions, but all those affected fully recovered within seven days. The meningitis signal previously reported remains in the older age category, including two cases reported after the booster dose of RTS,S. This could be a chance finding, as comparisons were made across groups for many different diseases, and because some of these cases happened years after vaccination without any obvious relationship to vaccination. The occurrence of meningitis will be followed closely during Phase IV studies, if RTS,S is licensed.

These data was part of submissions to the European Medicines Agency (EMA) in July 2014. The European Medicines Agency (EMA) is currently reviewing the regulatory application for RTS,S through the Art. They will also be shared with appropriate World Health Organisation (WHO) committees. All these agencies are expected to play various roles in the registration of the vaccine for use in future. A positive opinion from the EMAs Committee for Medicinal Products for Human Use, together with a potential policy recommendation from the World Health Organisation (anticipated by the end of 2015), would be the basis for licensure applications to National Regulatory Authorities in sub-Saharan African countries. If positive, these regulatory decisions would help pave the way for the introduction of RTS, S through African national immunisation programmes. If RTS, S is approved, GSK has committed to making the vaccine available at a not-for-profit price.