March 1, 2017

Testing vaccines by deliberately exposing human volunteers to disease-causing materials
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Human Experimental Challenge Models in
Vaccine Development:

A Historical Perspective


Myron M. Levine, MD, DTPH

Grollman Distinguished Professor
Assoc. Dean for Global Health, Vaccinology & Infectious Diseases
University of Maryland School of Medicine

Clubhouse Location:
Wine & Cheese: SOM Commons Area
Presentation: WHSCAB Auditorium
Moveable Feast Agenda:
6:00pm — wine, cheese, networking at SOM
6:30pm — meeting convenes at WHSCAB
7:45pm — casual buffet dinner and more networking at at SOM

Dear Vacciners,
As those of you who have been unlucky enough to find yourself standing in the vicinity when it happens well know, we signal the transition between the wine/cheese part of each VDC evening and the presentation/discussion part of the evening by vigorously ringing a cow bell.

This is in honor of Edward Jenner's implementation of a vaccine that used cowpox (the name 'vaccine' came from "vacca," the Latin word for cow) to prevent smallpox, thereby initiating a chain of events that ultimately led to the eradication of smallpox in humans*

Jenner got all the credit** but the real hero of the smallpox story is James Phipps, an 8 year old neighbor boy who was drafted into being Jenner's guinea pig. Here is a summary version of the experimental protocol: Make two cuts on James' arm, stuff them with fresh cowpox goop taken from a milkmaid Sarah Nelme's hand, wait a week until James gets well from the cowpox, then MORE THAN TWENTY TIMES over the next several months "Several slight punctures and incisions were made on both his arms, and the [smallpox] matter was carefully inserted, but no disease followed." Over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over and over.

Parish records state that in 1823 James Phipps attended Jenner's funeral. Probably just to make sure that he was actually dead.

On the other hand, maybe he actually attended the funeral to say thank you … alert VDC member-in-good-standing Rachel Marine turned up evidence that, after James grew up, Jenner gave him a house.

Fast forward to the 20th century and human challenge models have entered the mainstream. Sometimes for worse (Nazi Germany) but a lot of times for better (influenza, cholera, eColi, rotavirus, malaria).

As our presenter, Mike Levine et al, said in a Dec. 2012 article in the Lancet -- "Human microbial challenge: the ultimate animal model":

"Natural exposure to infections occurs throughout life, but the infection of human volunteers could be viewed as a dark art, antihippocratic, unnatural, risky, and even unethical. Studies of carefully monitored and controlled human infection, however, can provide unique insights into pathogenesis and be used to advance the development of antimicrobial drugs and vaccines."

Want to hear more about what it is like to purposefully make people sick in the pursuit of better, safer vaccines from a 1998 Albert B. Sabin Institute Gold Medal Award winner who has been spectacularly successful in using that approach?

Of course you do.


Hope to see you for dinner at the Club on Wednesday, March 1st.

* I was going to say "from the world" but there are still smallpox samples being kept legally at the CDC and in Russia and, from time to time, the occasional odd cardboard box full of vials of smallpox is still turning up in dusty cupboards.

**Ironically, (for poor James), Jenner was not actually the first person to deliberately try vaccination against smallpox through inoculation with cowpox. He was just the first person to do it and then publish the findings in the academic literature. Jenner and James Phipps did their pas de deux with destiny in 1796, but records and diaries here and there indicate that between 1769 and 1791 at least seven other people from England, Denmark, and Germany had already successfully tried cowpox inoculation on nearby children and/or family members.

Publish or perish, y'all.