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- A Stuijt
- Retired South African medical journalist, ex-Sunday Times of Johannesburg.
Wednesday, 1 June 2011
18:12 | Posted by A Stuijt | | Edit Post
Dutch company tested new TB-vaccine on nearly 2,800 South African babies
- Impoverished parents in Worcester received $15 per clinic visit from Dutch pharmaceutical company Crucell N.V. for allowing testing of experimental TB-vaccin on their healthy babies -
JOHANNESBURG(PlusNews, the news agency of the United Nations, reported)
The first phase of a trial to test the efficacy of a tuberculosis (TB) booster shot for babies has been completed in April 2011, with nearly 2,800 infants participating in the two-year trial, in which researchers from the South African Tuberculosis Vaccine Initiative (SATVI) hope to prove that their new vaccine can act as a booster shot to improve the efficacy of the only existing inoculation against TB: the 90-year-old Bacille Calmette-Guerin (BCG) vaccine. This is seenn to be growing increasingly resistant to the new strains of drug-resistant tuberculosis in South Africa - especially on HIV-positive infants.
File picture of South African infant: Red Cross Children's Hospital
The carer of each baby participating in the trial was paid R150 (US$15) per clinic visit. “This provides an incentive,” said Linda Sibeko, who lives in Worcester and is a member of this study's interim community advisory board. “However parents also saw it as a way of learning more about TB. People are welcoming it. We explained ... and now everyone wants to be involved."
Dutch biopharmaceutical company Crucell N.V. and the Aeras Global TB Vaccine Foundation announced the start of their clinical trials in infants of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35.
This was the world's first-ever clinical trial designed to test this vaccine candidate in infants - despite the fact that human babies cannot give their 'informed consent' to participate in such medical experiements....
- The claim is made that the AERAS-402/Crucell Ad35 vaccine candidate used on the babies was previously tested for safety in healthy adults in the United States and South Africa, and also in adults exposed to TB in South Africa and Kenya.
Current BCG vaccine does not protect against lung-TB
The 90-year-old BCG TB-vaccine has over the years become a standard part of national immunisation programmes in many countries, including in South Africa, but it does not guarantee protection against the most common form of TB, which attacks the lungs. An effective TB vaccine could help save some of the two million people who die annually from the disease, a quarter of whom are co-infected with HIV, Irin news writes. The vast majority of patients dying of the incurable form of the bacterial disease, extremely-drug-resistant Tuberculosis, live in South Africa.
First time infants are used as guinea-pigs in TB-drug trial
The vaccine has thus far been tested in HIV-infected adults in South Africa, the UK and Senegal, but because this will be the first test in infants – and only healthy, i.e. HIV-negative infants were enrolled.
- According to Michele Tameris, study manager for the trial, the vaccine has already been administered to infants in Gambia, "with no side-effects other than a brief period of mild discomfort, and the irritation and swelling at the injection site usually associated with childhood immunisations."
Dr Glenda Grey, co-director of the Perinatal HIV Research Unit at Witwatersrand University, which participated in South Africa's first human clinical trial for an HIV vaccine in 2003, said oversight bodies "demanded a higher burden of proof when children and infants were included in studies.
- "Ethics committees must also ensure that infants don't find themselves in a more vulnerable position than they already are because they participated in a trial; you have to minimise the harm and maximise the benefits," she said. You have to make sure the parents or caregivers understand the ... risks and benefits ...and that their child is contributing to science..’
"Does a child benefit from being in the study? They often do. The nice thing ... [is that] any illness is diagnosed much earlier and [they] get treatment, whereas ... [other children] may not be able to get to a clinic, may be misdiagnosed or get poor treatment," said Grey.
Consent is always a crucial issue. "You also have to make sure the parents or caregivers understand the informed-consent process, the risks and benefits, that a vaccine may or may not work, and that their child is contributing to science."
Ethics in practice The town of Worcester, in the winelands of Western Cape Province, is one of three towns participating in the SATVI trial. This town has the dubious honour of having the highest concentration of residents co-infected with HIV/AIDS and Tuberculosis. These co-infections have also been the most important cause of ‘premature death “in the province since 2007, Tameris said.
“The blood samples taken in this study would be much smaller, and would also be taken less often, because drawing adult-sized samples from pint-sized participants could mean risking anaemia or other illnesses. You have to work out the absolute minimum sample you need, down to microlitres. Babies are very sweet and cute, but it's not always easy when they become distressed and resent having to be held tightly to have blood taken," she said.
‘Blessing in disguise’
The South African Department of Health estimated that almost 90 percent of children under the age of one were immunised with the old TB vaccine in 2008. "We have very high immunisation rates in South Africa so we have a culture of immunising our children and, in that sense, vaccine trials are easier and more understandable than drug trials to many people," Grey noted.
Although there have been concerns that the legally mandated R150 (US$19) given to participants per clinic visit could provide a (financial) incentive, Linda Sibeko, who lives in Worcester and is a member of the study's interim community advisory board, said parents saw it as a way of learning more about TB. "People are welcoming it. We explained ... and now everyone wants to be involved."
DUTCH PHARMACEUTICAL COMPANY CRUCELL N.V.
May 28 2009 - Dutch biopharmaceutical company Crucell N.V. and the Aeras Global TB Vaccine Foundation today announced the start of a Phase I clinical trial in infants of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35. This is the first clinical trial designed to test this vaccine candidate in infants.
- The Phase I study of AERAS-402/Crucell Ad35 will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) in the Western Cape region of South Africa.
The main objective of the study will be to test the safety of the TB vaccine candidate in infants previously vaccinated with the (old) Bacille Calmette-Guérin (BCG) vaccine, which is currently the only vaccine licensed to help prevent TB.
There now is more TB than ever before, despite the BCG-vaccine…
The AERAS-402/Crucell Ad35 vaccine candidate has previously been tested for safety in healthy adults in the United States and South Africa, and adults exposed to TB in South Africa and Kenya.
"BCG is the most widely administered vaccine globally, yet there is more TB now than ever before," said Dr. Jerald C. Sadoff, President and CEO of the Aeras Global TB Vaccine Foundation.
- "We are testing AERAS-402/Crucell Ad35 as a booster vaccine to BCG or to a recombinant BCG to stimulate the body's immune response and improve protection against TB. The AERAS-402/Crucell Ad35 vaccine is inducing the highest CD8 T cell responses in humans we have seen with any TB vaccine."
- Fifty-four healthy infants who have not been exposed to TB or HIV will be enrolled in the Phase One of the study.
Dr Jaap Goudsmit – pleased with collaboration:
"We are very pleased that the collaboration with Aeras and SATVI enables us to enter into this new trial," said Dr. Jaap Goudsmit, Crucell's Chief Scientific Officer at its start two years ago. "Using Crucell's technologies, we are on a joint mission to develop a new vaccine against TB that could increase the number of people protected from infectious diseases worldwide."
In 2004, Aeras and Crucell began jointly developing this vaccine candidate using Crucell's AdVac® vaccine technology and PER.C6® manufacturing technology.
- A first Phase I clinical trial launched in October 2006 in Kansas, USA indicated that the vaccine candidate is safe in healthy adults who have not previously been immunized with BCG in the USA.
Results of a second study, launched in May 2007 in South Africa, were presented at the ‘TB Vaccines for the World' conference in April 2008.
- Preliminary data demonstrated induction of both critical arms of the cellular immune system, CD4 and CD8 immune T-cells, and showed that in those participants who responded, CD8 immune responses were much higher than had ever previously been seen in a TB vaccine study.
A third phase I study in healthy adults in St. Louis, Missouri, USA was launched in December 2007 focusing on the immunogenicity and safety of two AERAS-402/Crucell Ad35 boost doses administered at three to six month intervals after BCG priming in healthy adults. Data from this study indicate that two injections of AERAS-402/Crucell Ad35 are immunogenic; these responses and those seen in South African adult volunteers given BCG around birth are some of the highest CD8 T cell responses ever seen in a TB vaccine study. This immune response is greater than that detected in the absence of BCG prime, supporting the possible utility of AERAS-402/Crucell Ad35 as a booster vaccine. BCG prime alone shows limited immunogenicity.
- An ongoing study in St. Louis, Missouri, USA is evaluating a longer prime-boost interval. The study has been fully enrolled and has discovered no safety issues. Immunological data are expected to be available in the first half of 2009.
And a Phase I clinical trial of the jointly developed TB vaccine was started in Kenya in October 2008.
- The study is being conducted by the KEMRI/Walter Reed Project-Kisumu at their Kombewa Clinical Trials Center near Kisumu, in Western Kenya.
- Its main objective will be to test the safety of the candidate vaccine in BCG-vaccinated adults with or without latent tuberculosis. This study is fully enrolled and is now in its follow-up segment, with no safety issues identified.
In October 2008, enrollment for the first Phase II study of AERAS-402/Crucell Ad35 was started in Cape Town, South Africa on 82 healthy adults who were all cured of active TB.
- The study was conducted by the University of Cape Town Lung Institute in conjunction with SATVI..
Johannesburg, 1 July 2009. HIV-positive babies who receive the global standard tuberculosis vaccine (BCG), which contains live organisms, is fatal to more than 70 percent of the infants infected with it. This shock finding was made during a new study published in Bulletin, a journal published by the World Health Organisation (WHO). Read the entire report: http://www.who.int/bulletin/volumes/87/7/08-055657.pdf
HIV-positive babies who received the Bacillus Calmette-Guérin (BCG) vaccine were three times more likely to contract TB and die from the vaccine than previously believed: earlier studies had documented HIV-positive infants being at risk double that of healthy infants.
The live cultures in the BCG-vaccine, which was first developed over ninety years ago, is fatal to more than 70 percent of all infants infected with the human-immune deficiency virus, the latest study has found.
According to UNAIDS, an estimated 420,000 children worldwide receive the BCG vaccination annually. An intensive field-testing programme with a new TB-vaccine is being also being carried out in Worcester, South Africa by a Dutch pharmaceutical company on a group of healthy infants, spearheadingthe world’s increasingly urgent search for a new, more effective vaccine against one of mankind’s oldest disease scourges.
Vaccine does not guarantee protection against lung-TB
BCG TB-vaccine has over the years become a standard part of national immunisation programmes in many countries, including in South Africa, but it does not guarantee protection against the most common form of TB, which attacks the lungs.
- An effective TB vaccine could help save some of the two million people who die annually from the disease, a quarter of whom are co-infected with HIV. The vast majority of patients dying of the incurable form of the bacterial disease, extremely-drug-resistant Tuberculosis, live in South Africa. More details on this testing programme on small infants are published below this article.
Put diagnosed babies on antiretroviral medication early…
- "There are more complications in HIV-infected infants vaccinated with this BCG strain ... we need to look further into what we can do to prevent the disseminated BCG disease from developing in HIV-infected patients," he told the United Nation’s news agency, IRIN/PlusNews. "Doctors should be aware, and should pick it up early. Once you have identified a patient as HIV-positive, and you know that they have received BCG, you can start antiretroviral [medication] early and probably prevent the negative consequences."
The study's authors acknowledged that diagnosing babies with HIV was difficult, with most developing countries only testing infants at six weeks of age, if at all. A blanket postponement of vaccination would only increase the vulnerability of most babies to TB.
- According to UNAIDS, an estimated 420,000 children worldwide receive the BCG vaccination annually.