first we had to have a serious physical to see if we were up to snuff for the study. we all passed with flying colors. then we started the inoculations. we were given 3 dosages of either the vaccine pre addition of a protein, the vaccine with protein, or a placebo (no vaccine at all) over the course of 3 months.
each week we drove to walter reed medical research center in silver spring, md at 5:30 am to have our blood drawn and earn about $50 (? lindsay how much did each draw earn us?). the drive was about 45 minutes. the time was filled with very heady conversation. we decided we would write a book: "the malaria monologues." we didn't.
during one drive the conversation was so good that we missed getting on the capitol beltway and ended up turning around at BWI--a mistake that cost us at least one hour.
lindsay eventually dropped out because she got a fellowship to germany. melanie and i got to "test" the vaccine.
we were taken to a very different part of walter reed. way more lab coats. no windows. curious boxes etc. we were escorted into a part of the building with mosquito stuff everywhere. lots of malaria charts. there were boxes of caged mosquitos. we sat down at a table. we were asked to expose our forearms and place the meaty portion of our arms over a dixie cup with a screen over it. in the cup were 5 malaria infected starving mosquitoes.
we sat with our arms on the malaria dixie cups for exactly 5 minutes. the little buggers just went to town on our arms. then they removed the cup from our arms and examined the mosquitoes proboscis for both my blood and the parasite. my little guys all did their work well. melanie had to do it again. one of her mosquitoes hadn't eaten. so they put another mosquito (just one) in the cup and she sat again for 5 minutes.
it was really weird to sit there realizing that i inflicting myself with malaria. i had seen people with it in africa and i never wanted that miserable disease. but then, that is why i was doing it. i was hoping that i could help in the process of getting this vaccine so that less people were infected.
after 10 days we had to go to walter reed EVERY day to have our blood checked for the parasite and at a certain point they had all of the "human subjects" check into the hilton in silver spring so they could monitor us. we had to have morning and evening blood draws. melanie got sick about 14 days into it. she was really miserable. i took care of her a couple of nights but i felt fine.
at some point i decided i didn't want to stay at the hotel anymore. it was just a pain in the butt to commute and stuff. near the end of the trial: day 22 i had a HUGE meeting at HHS. so i skipped the evening draw and planned to skip the morning draw for the meeting. i seemed fine and didn't really want to lose the time driving.
you can guess what happened. in the middle of the night i started to feel like i had the flu. i called, but the nurse on duty was a temp and she didn't know me or much about what she was doing and told me just to come in the morning. i couldn't because of the meeting and i explained that to her. she didn't seem to care. i figured, must just be the flu.
by morning i was shaking and sweating. determined, i still attended the meeting. but during lunch went and had my blood drawn. they gave me some chloroquine and said they would call with results. soon i was bestowed the honor of having the highest parasite count of all the human subjects (i had the worst case). the chloroquine really tripped me out. driving home from my second blood draw of the day i called my friend katharine lost in my own city. i guess i said some crazy stuff???
i was sick for a long time. i was training for a "team in training" triathlon for denny allred who at the time was suffering with multiple myloma. the triathlon was 2 weeks away. the malaria really slowed down my time, but it was still fun.
anyway, the other day i read the following in the UN news and felt like all i had suffered had been more than worth it.
(btw, i made actually no money for the whole thing. i was taxed on my earnings from there and i think it took almost all of it) still this makes it all worth it!!!!!!!
Africa: Breakthrough in Malaria Vaccine Trials
UN Integrated Regional Information Networks
19 October 2007
Johannesburg
An anti-malaria vaccine offering improved protection to children could be registered for use in four years, potentially saving millions of young lives, new research conducted in Mozambique has shown.
Scientists announced this week that a clinical trial involving 214 infants had confirmed the safety of the RTS,S/AS02D malaria vaccine. More children die of malaria than any other disease - over one million every year, most of whom are African children under five - and it is a major reason why Mozambique still has one of the world's highest child mortality rates, according to the UN Children's Fund (UNICEF).
Research by Dr Pedro Alonso, of the Manhica Health Research Centre, in Mozambique, and the Hospital Clinic of the Universitat de Barcelona, in Spain, and colleagues, indicated that the vaccine could reduce the risk of new infections by 65 percent. A previous trial in 2004 indicated 45 percent effectiveness for the same vaccine.
Global pharmaceutical company GlaxoSmithKline, with the help of the Malaria Vaccine Initiative by PATH, an international, non-profit health organisation, are developing it.
The children were randomly split into two groups, one assigned to receive three doses of the vaccine and the other to receive a hepatitis B vaccine as a control, at ages 10 weeks, 14 weeks and 18 weeks. Initial findings were published in the British medical journal, the Lancet.
Researchers said the candidate vaccine was "safe, well-tolerated and highly immunogenic [evoked a strong immune response] in young infants living in a rural area of southern Mozambique", and that the study had provided evidence of a strong association between vaccine-induced antibodies and a reduced risk of malaria infection.
"We have shown that a vaccine can reduce the risk of malaria infection in young African infants exposed to intense transmission of P. falciparum," the researchers said. Plasmodium falciparum is the most lethal of the four strains of the malaria parasite that infect humans: an initial severe infection can kill up to one in four victims unless they receive medical help.
The parasite has developed resistance to many of the older and cheaper drugs being phased out in line with World Health Organisation (WHO) guidelines, but only a tiny percentage of African children are treated with the new, more expensive and effective combination therapies.
First steps
The complex life cycle of the parasite, and its ability to remain undetected by the human immune system, means a long-lasting vaccine that is close to being totally effective is still many years away. The parasite also undergoes various changes as it develops in the mosquito - the vector, or main carrier, of the disease - as well as in the human liver, blood system, and red blood cells, making it difficult to target.
Vaccines in development tend to target different stages of the parasite's life cycle in humans, and the RTS,S/AS02D candidate vaccine aims to reduce its ability to infect and proliferate in the liver.
Repeated malarial infections result in a natural immunity if the person survives the first bouts. Adults and older children living in endemic malaria areas can show no clinical signs of the disease, even though they may be infected with the parasite. Older children may be more able to survive their first attack of malaria, which can damage the liver, kidneys and central nervous system, including the brain.
There is no easy way to fight malaria, but until the development of a vaccine that can totally prevent infection, preventing deaths by deferring infection among young children and reducing the severity of the disease are the best strategy.
According to the researchers, the vaccine would be effective as part of a layered strategy against malaria, including the provision of insecticide-treated bed nets (ITNs) and spraying insecticides to protect people against mosquitoes. According to the WHO, if used properly, ITNs can cut malaria transmission by at least 60 percent and child deaths by a fifth.
1 comment:
the head of our vaccine study center at school said he used to sign up for every trial back when he was a med student. apparently he and his roommate did the malaria thing back then and the roommate came down with malaria, so they gave him an extra $1000. you got ripped off!
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