Lyme Disease Vaccine: Hope or Hype?

Lyme Disease Foundation - Press Release
Sept 13, 1997

Hartford, CT - As the news about two vaccines is being released, we need to ask if this is hope for a real solution to a public health crisis or hype to grab onto the 100-200 million dollar Jackpot?

The Lyme Disease Foundation is very optimistic about the upcoming announcements of the results of the three -year vaccine trials. "We have always believed that the development of a Lyme disease vaccine was the best solution to the growing epidemic, even before any manufacturer decided to develop one. But, as the trial results are presented to the general public, we must have answers to the two most fundamental questions. Is it safe? Does it protect people from Lyme disease?" Says Karen Vanderhoof-Forschner, MBA, CPCU, CLU, Chair, Board of Directors of the Lyme Disease Foundation. Are the results being fully discussed in a full scientific presentation in front of Lyme disease knowledgeable professionals?

Failure to ask the tough questions, as the media places this news into headlines, can result in both false hope and people discarding vital prevention strategies. The result of false hope could mean increased cases of Lyme disease, other tick-borne disorders, and additional human suffering. Vaccine manufacturers will welcome discussion of these questions.

The announcements are being released in two separate poster abstracts at the 1997 Infectious Disease Society Association's 1997 meeting. Both vaccines are recombinants of an outer surface protein (Osp) A of the Lyme bacterium - Borrelia burgdorferi, which was discovered by LDF Board member Willy Burgdorfer, PhD, MD (hon).

So far over 102,000 cases of confirmed Lyme disease have been reported to the government. This represents the tip of the iceberg in terms of the total cases of Lyme disease - which could be closer to 2 million. If the vaccine is a success it could stem the rising cost of Lyme disease to Society (which is about $1 billion) and reduce the personal and professional devastations that have been occurring to families across the United States.

The following are concerns already expressed within the scientific community and general public:

1. Is it safe?
It appears to be safe when given to healthy people who do not have Lyme disease. But the LDF has been cautioned by scientists concerned that theyhave not yet discovered what all the pieces of OspA do. Is this important? It may be. Think of OspA as a large molecule, having 100 - 1,000 subpieces. Some of those pieces may cause a high antibody response. Others may cause a protective response. Yet, others may cause damage, which may take years to be detected.

2. Is OspA protective?
The vaccine is immunogenic, meaning it does cause a strong antibody response - but is this response protective? Questions have been raised by some published studies. Padilla et al. (1996-University of Wisconsin School of Medicine), conducted borreliacidal antibody research on the bloods of patients who had the vaccine and in hamsters. This test measures productive antibody response. The conclusion was that high levels of antibody were produced, the protective portion was short-lived, with many people not having protection by 180 days after the second injection. Leaving some people unprotected from infection. Another finding has been that high antibody levels did not correlate to the vaccine's effectiveness. Therefore, blood tests could not be used as criteria for success or failure. Finally the research found that the protective response did protect against various strains for a very limited time. And, that later, the protection was limit to the strain used in the vaccine's development. There are about 100 strains in the US.
A 1997 study by Foley et al (UCLA School of Medicine) also found that the vaccine antibody test results did not correlate with the status of immunity. And, that a state of partial immunity can occur where the subject could have infection harbored in the skin, yet have neither a rash nor overt evidence of infection. This may result in "partial immunity " that could "potentially mask infection." This potentially means that after several years of vaccines, the patient may decide to forgo further vaccinations, resulting in the bacteria leaving the skin and establishing disease. Further, their data strongly suggested that another immuogen(s) was responsible for the protective immune response.

3. What are the trials designs?
What are the criteria for success and failure? Reliance on the governments case reporting criteria does miss many cases of real disease. And, the CDC does state that their definition is not for clinical use - and how much more clinical could something get? How were the patients followed? Did all patients receive in-person physical or yearly blood tests/evaluations? What monitoring of the patients was done? By mail? In person - was blood drawn and were "silent converters" caught early. These are the people who are infected but not yet symptomatic.

4. Do the Principle Investigators (PI) believe a vaccine is needed?
Both principle investigators have stated that Lyme disease is easy to diagnose and treat. And, that Lyme disease is over diagnosed and overtreated. Then, why are they conducting trials on a product that may not be needed?

5. This is both Good News and Bad News
The good news is that the vaccines have the real potential to work and help stem a public health crisis. These may indeed work! The Bad News is that it may take several years of scientific presentations and debate before the FDA approves these for widespread public use. And, once released, the vaccines may be restricted to a government bureaucrats view of who should be allowed to have it, and not be open to all who want it. If these vaccines work, then this will be the second most important scientific advancement in the 100 year history of Lyme disease.

	SmithKline Beecham	Pasteur Merieux Connaught
Number of people:	10,906 entering	10,306 entering
Drop-out rate:	9%	25%
Centers:	Multiple centers in endemic areas	14 centers in endemic areas
Ages:	15-70	18-92
Injection Schedule:	3 injections - 0, 1 mo., 12 mo.	3 injections - 0, 1 mo., 12 mo.
Biochemical:	Recombinant adjuvanted Bb outer surface protein (Osp) A.	Recombinant Bb outer surface protein (Osp) A.
Monitoring:	Suspected LD cultured, PCR, serologic test. Blood tests at beginning (0), 12 mo., 20 mo.	Blood drawn at rash (unclear if any other tests were done).
Group:	People with positive blood tests excluded. People with Lyme disease excluded.	LD patients included.
Efficacy:	¾ 65: 3 doses 90% Overall: 2 doses 50%. 3 doses 79%. (If people w/asymptomatic infection "silent converters" were incl. as successes, then protection was 82% after dose 2 and 100% after dose 3. But, these people were counted as treatment failures.)	¾ 59: 2 doses 82%. 3 doses 100% No testing for antibody conversion, without specific limited signs and symptoms. "Silent converters" missed.
Treatment Failure:	Failures were those whose blood tests went from negative to positive. Unclear what other criteria for failures were used.	Failures must have a positive blood test and meet the CDC LD Case reporting definition. EM rash alone may not have qualified.
Special Note:	„ 66 less protection. Mild to moderate local & general self-limited side effects.	„ 60: No efficacy after 2 doses. 75% after 3rd dose. "generally well tolerated."

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